MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-08 for 7 FR VIDA PTV CATHETER VDA100144 manufactured by Bard Peripheral Vascular, Inc..
[33369419]
The lot number for the device has been provided. A review of the device history records is currently being performed. The device has been returned to the manufacturer for evaluation. The investigation 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
[33369420]
It was reported that the balloon valvuloplasty catheter was allegedly difficult to retract through the sheath after use in the svc. It was further reported that upon removal from the sheath the fibers of the balloon were allegedly unraveled. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
[39111763]
A manufacturing review was conducted. The lot met all release criteria. Visual/microscopic inspection: the device was returned used. The balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 14mm x 4cm x 100cm balloon. Loose fibers were noted at the distal cone. Fiber strands were noted to be unraveled at this location, measuring 45. 2cm in length. The outer pebax layer was also peeling off the balloon at this location. The balloon was returned partially inflated. No other anomalies were observed along the length of the device. Functional/performance evaluation: the patency of the guidewire lumen was tested using an in-house 0. 035? Guidewire, and it passed without issue. The inflation hub was connected to an inflation device and the partially inflated balloon was able to be deflated without issue. An attempt was made to inflate the balloon. Upon inflation, the balloon inflated asymmetrically and ruptured at 3atm. The balloon rupturing is an incidental finding, as it was not reported by the user and likely ruptured due to the unraveled fibers and peeled pebax. The rupture was located 1. 2cm from the distal tip and extended longitudally for 2. 3cm. No further functional testing could be performed due to sample condition (i. E. Unraveled fibers and balloon rupture)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 unraveled fibers and peeled pebax. The investigation is inconclusive for sheath related retraction issues, as functional testing for sheath retraction issues could not be performed due to the poor sample condition (i. E. Unraveled fibers). The balloon was inflated near a stent and there may have been an interaction between the stent and balloon which contributed to the unraveled fibers and peeled pebax. The balloon was also returned partially inflated. Therefore, it is possible that the user did not fully deflate the balloon, resulting in the retraction difficulty through the introducer sheath. The partially inflated balloon was able to be deflated without issue during functional testing. 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 vida ptv catheter instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020394-2015-01978 |
| MDR Report Key | 5275178 |
| Date Received | 2015-12-08 |
| Date of Report | 2015-11-12 |
| Date of Event | 2015-11-10 |
| Date Mfgr Received | 2016-02-23 |
| Device Manufacturer Date | 2015-08-25 |
| Date Added to Maude | 2015-12-08 |
| 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 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 | 7 FR VIDA PTV CATHETER |
| Generic Name | BALLOON VALVULOPLASTY CATHETER |
| Product Code | OMZ |
| Date Received | 2015-12-08 |
| Returned To Mfg | 2015-11-24 |
| Catalog Number | VDA100144 |
| Lot Number | 93HZ0123 |
| Device Expiration Date | 2018-08-31 |
| 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 WEST 3RD ST. TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-12-08 |