MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2016-05-03 for VIDA PTV CATHETER VDA100166 manufactured by Bard Peripheral Vascular, Inc..
[44361620]
No medical records or medical images have been made available to the manufacturer. As the lot number for the device was provided, a review of the device history records is currently being performed. The device has been returned to the manufacturer for evaluation. 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.
Patient Sequence No: 1, Text Type: N, H10
[44361621]
It was reported that during treatment in the mid sfa, the health care provider alleged that only one marker band was visible under fluoroscopy. It was further reported that the balloon was inflated under low pressure to locate the position of the balloon and then treated the lesion without issue. The procedure was completed with the original device. There was no reported injury.
Patient Sequence No: 1, Text Type: D, B5
[47818200]
Manufacturing review: a manufacturing review was conducted. The lot met all release criteria. Visual inspection: the sample was returned. The balloon size was printed on the balloon hub of the catheter and identified the returned sample as a 16mm x 6cm balloon. The balloon appeared to have been previously inflated. No other anomalies were observed. X-ray: the balloon was examined via x-ray imaging prior to functional testing, and the marker bands were not visible. Functional/performance evaluation: the balloon was cut using a razor in order to determine whether the marker bands were present. Upon opening the balloon, both marker bands were missing from the inner catheter. The glue bullet was intact and in the correct location, indicating that the marker bands did not move further proximal on the inner catheter shaft. No damage was noted to the catheter and the marker bands were not present. Medical records review: as medical records were not provided, a review could not be performed. Image/photo review: no medical images have been made available to the manufacturer. Conclusion: the investigation is confirmed for component missing, as both marker bands were missing on the returned device. The missing marker bands is a supplier related issue. 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: carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used. Do not use if product damage is evident. Dilatation procedures should be conducted under high-quality fluoroscopic guidance. 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. 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
| Report Number | 2020394-2016-00416 |
| MDR Report Key | 5628520 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-05-03 |
| Date of Report | 2016-04-07 |
| Date of Event | 2016-04-07 |
| Date Mfgr Received | 2016-06-14 |
| Device Manufacturer Date | 2016-01-05 |
| Date Added to Maude | 2016-05-03 |
| 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 | 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 PTV CATHETER |
| Generic Name | PTA DILATATION BALLOON CATHETER |
| Product Code | OMZ |
| Date Received | 2016-05-03 |
| Returned To Mfg | 2016-04-14 |
| Catalog Number | VDA100166 |
| Lot Number | 93LZ0217 |
| Device Expiration Date | 2019-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-05-03 |