MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-15 for VIDA PULMONARY VALVULOPLASTY CATHETER VDE100184 manufactured by Bard Peripheral Vascular, Inc..
[33593282]
No device, no medical records or no medical images have been made available to the manufacturer. As the lot number for the device has been provided, a review of the device history records (dhr) is being performed. The investigation of the reported event is currently underway. 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. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[33593283]
It was reported that during a balloon aortic valvuloplasty procedure (bav), the balloon was allegedly difficult and slow to deflate in the aortic annulus (remained inflated for more than 10 seconds). There was no reported retraction difficulty through the sheath. Reportedly, another balloon catheter was used to complete the procedure. There was no known reported impact or consequence to the patient.
Patient Sequence No: 1, Text Type: D, B5
[36376191]
As the lot number was provided, a review of the device history record was performed. The lot met all release criteria. No issues were identified during the manufacturing process or quality control inspections. No internal non-conforming reports were issued with the lot relating to the reported complaint. This is the only complaint reported for this lot number for this failure mode. Visual inspection & functional/performance evaluation: the sample was not returned for evaluation; therefore, a visual inspection and a functional/performance evaluation could not be performed. Medical records & image/photo review: no medical records or photos/images were returned for review. Conclusion: the investigation is inconclusive, as the sample was not returned for evaluation. The definitive root cause could not be determined based upon the available information. It is unknown if patient and/or procedural issues contributed to the reported event. Labeling review: the current ifu (instructions for use) states: warnings: when the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated. If resistance is met during manipulation, determine the cause of the resistance before proceeding. Applying excessive force to the catheter can result in tip breakage or balloon separation. Precautions: use the recommended balloon inflation medium of approximately 25 to 75 contrast to saline ratio. Never use air or other gaseous medium to inflate the balloon. If resistance is felt during post procedure withdrawal of the catheter through the introducer sheath, determine if contrast is trapped in the balloon with fluoroscopy. If contrast is present, push the balloon out of the sheath and then completely evacuate the contrast before proceeding to withdraw the balloon. Use of the vida ptv dilatation catheter: position the balloon relative to the valve to be dilated, ensure the guidewire is in place and, while ensuring the balloon is held in a static position, inflate the balloon to the appropriate pressure. Apply negative pressure to fully evacuate fluid from the balloon. Confirm that the balloon is fully deflated under fluoroscopy. While maintaining negative pressure and the position of the guidewire, withdraw the deflated catheter over the wire through the introducer sheath. Use of a gentle counter clockwise motion may be used to help facilitate catheter removal through the introducer sheath.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020394-2015-02015 |
| MDR Report Key | 5299711 |
| Date Received | 2015-12-15 |
| Date of Report | 2015-11-18 |
| Date of Event | 2015-11-18 |
| Date Mfgr Received | 2016-01-13 |
| Device Manufacturer Date | 2014-04-22 |
| Date Added to Maude | 2015-12-15 |
| 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 WEST 3RD ST. |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | FUTUREMATRIX INTERVENTIONAL |
| Manufacturer Street | 1605 ENTERPRISE STREET |
| Manufacturer City | ATHENS TX 75751 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75751 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDA PULMONARY VALVULOPLASTY CATHETER |
| Generic Name | PULMONARY VALVULOPLASTY CATHETER |
| Product Code | OMZ |
| Date Received | 2015-12-15 |
| Catalog Number | VDE100184 |
| Lot Number | 93DY0141 |
| Device Expiration Date | 2017-04-30 |
| 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 WEST 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2015-12-15 |