MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,company representative,hea report with the FDA on 2015-04-15 for VIDA PTV CATHETER VDA100122 manufactured by Bard Peripheral Vascular, Inc..
[5877328]
It was reported that prior to patient use, the outer catheter shaft broke. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[13395008]
A further clinical review was performed and identified this event to be mdr reportable pursuant to 21 cfr part 803. The device history records have been reviewed with special attention to the raw materials, the subassemblies, the manufacturing process and the quality control testing. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only complaint reported to date for this failure mode. The device was returned. The investigation is confirmed for a break, as a complete circumferential outer shaft break was found at the proximal balloon joint. Based on the visual inspection of the break, it appeared that excessive force may have been applied to the catheter shaft, as the edges of the break were uneven and stretched. However, the definitive root cause for the outer shaft break could not be determined. Potential complications related to a break is adequately addressed in the current ifu (instructions for use). 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
[28478814]
To ensure compliance to 21 cfr 803. 50 a retrospective review of this file was conducted to determine if good faith efforts were made to obtain the required information and/or an explanation of why any required information was not provided. Multiple follow up attempts were made with the facility to obtain any information pertaining to the patient, product, and/or procedural details (e. G. Date of the event, relevant test data, relevant history, lot #, catalog #, implant and/or explanted dates, and concomitant product(s) or therapy) that were not previously obtained during the initial investigation. The report source did not have any additional details to provide at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020394-2015-00235 |
| MDR Report Key | 4781434 |
| Report Source | 07,COMPANY REPRESENTATIVE,HEA |
| Date Received | 2015-04-15 |
| Date of Report | 2014-03-17 |
| Date of Event | 2014-03-17 |
| Date Mfgr Received | 2015-09-09 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2015-06-17 |
| 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 PTV CATHETER |
| Product Code | OMZ |
| Date Received | 2015-04-15 |
| Returned To Mfg | 2014-03-25 |
| Catalog Number | VDA100122 |
| Lot Number | 93HX0100 |
| Device Expiration Date | 2015-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2015-04-15 |