MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2018-04-11 for TRUE DILATATION CATHETER 0204511 manufactured by Bard Peripheral Vascular, Inc..
[105171696]
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) 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. 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
[105171697]
It was reported that during a tavr procedure, the balloon allegedly ruptured during an inflation attempt. It was further reported that there was difficulty retracting the balloon through the 14fr sheath. Upon removing the balloon and sheath together as one unit, a segment of the balloon material allegedly detached and became lodged in the external iliac artery. Multiple attempts to remove the balloon segment including upsizing to a 16fr sheath and the use of a snare were unsuccessful. The health care provider decided to send the patient to surgery for removal of the balloon segment. There was no reported patient injury post surgical extraction of the balloon segment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020394-2018-00367 |
| MDR Report Key | 7421972 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2018-04-11 |
| Date of Report | 2018-04-11 |
| Date Mfgr Received | 2018-03-19 |
| Date Added to Maude | 2018-04-11 |
| 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 DILATATION CATHETER |
| Generic Name | BALLOON VALVULOPLASTY CATHETER |
| Product Code | OZT |
| Date Received | 2018-04-11 |
| Catalog Number | 0204511 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2018-04-11 |