MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-03-08 for TRUE FLOW DILATATION CATHETER TF0263516 manufactured by Bard Peripheral Vascular, Inc..
[101948919]
As the lot number for the device was not provided, a manufacturing review could not be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable. Image review: the guided fluoroscopy image was a magnified ap projection that demonstrated approximately three thoracic vertebral bodies, part of the sternum, and the proximal end of several ribs. The magnified image demonstrated a heart valve overlying the thoracic spine in a perpendicular fashion. The proximal end of the heart valve was flared; however, the rest of the valve remained uniform in size with the distal end tapered inward. Two distal temporary pacemaker wires were demonstrated in the image. The guided fluoroscopy image demonstrated a pigtail catheter descending superiorly to the heart valve, the distal end of the pigtail catheter overlapping the proximal end of the heart valve. Based on images it cannot be determined if the pigtail catheter was intertwined within the heart valve. A balloon catheter system with a wire was advanced beyond the valve; the two (2) marker bands from the catheter system were positioned within the valve and extending from the mid to distal end of the valve. The identity of the balloon catheter system cannot be determined as no balloon inflation within the valve was demonstrated. Based on the images provided, the proximal end of the heart valve was flared; however, the rest of the valve remained uniform in size with the distal end tapered inward can be confirmed. Based on the images provided, a balloon catheter system with a wire advanced beyond the valve, two (2) marker bands were demonstrated to be positioned within the valve and extending from the mid to distal end of the valve can be confirmed. Based on the images provided, the identity of the balloon catheter system cannot be determined as no balloon inflation within the valve was demonstrated. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[101948920]
It was reported that during a tavr procedure access was gained through the arm and a heart valve was implanted. The health care provider(hcp) used a valvuloplasty balloon to post dilate the valve. The balloon inflated and deflated successfully inside the valve, but during retraction the valvuloplasty balloon allegedly pulled the heart valve back with it and out of the aortic valve, into the ascending aorta. The hcp proceeded to open the patient to retrieve the valve, which resulted in complications that lead to the patient expiring.
Patient Sequence No: 1, Text Type: D, B5
[106073383]
As the lot number for the device was not provided, a manufacturing review could not be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable. Image review: the guided fluoroscopy image was a magnified ap projection that demonstrated approximately three thoracic vertebral bodies, part of the sternum, and the proximal end of several ribs. The magnified image demonstrated a heart valve overlying the thoracic spine in a perpendicular fashion. The proximal end of the heart valve was flared; however, the rest of the valve remained uniform in size with the distal end tapered inward. Two distal temporary pacemaker wires were demonstrated in the image. The guided fluoroscopy image demonstrated a pigtail catheter descending superiorly to the heart valve, the distal end of the pigtail catheter overlapping the proximal end of the heart valve. Based on images it cannot be determined if the pigtail catheter was intertwined within the heart valve. A balloon catheter system with a wire was advanced beyond the valve; the two (2) marker bands from the catheter system were positioned within the valve and extending from the mid to distal end of the valve. The identity of the balloon catheter system cannot be determined as no balloon inflation within the valve was demonstrated. Based on the images provided, the proximal end of the heart valve was flared; however, the rest of the valve remained uniform in size with the distal end tapered inward can be confirmed. Based on the images provided, a balloon catheter system with a wire advanced beyond the valve, two (2) marker bands were demonstrated to be positioned within the valve and extending from the mid to distal end of the valve can be confirmed. Based on the images provided, the identity of the balloon catheter system cannot be determined as no balloon inflation within the valve was demonstrated. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[106073384]
It was reported that during a tavr procedure, access was gained through the arm and a heart valve was implanted. The health care provider(hcp) used a valvuloplasty balloon to post dilate the valve. The balloon inflated and deflated successfully inside the valve, but during retraction the valvuloplasty balloon allegedly pulled the heart valve back with it and out of the aortic valve, into the ascending aorta. The hcp proceeded to open the patient to retrieve the valve, which resulted in complications that lead to the patient expiring.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2018-00211 |
| MDR Report Key | 7325701 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-03-08 |
| Date of Report | 2018-04-06 |
| Date Mfgr Received | 2018-04-06 |
| Date Added to Maude | 2018-03-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JUDITH LUDWIG |
| Manufacturer Street | 1625 W 3RD ST. |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | C.R. BARD, INC. (GFO) |
| Manufacturer Street | 289 BAY ROAD |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUE FLOW DILATATION CATHETER |
| Generic Name | VALVULOPLASTY BALLOON |
| Product Code | OZT |
| Date Received | 2018-03-08 |
| Catalog Number | TF0263516 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 W 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-03-08 |