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 2014-12-10 for VIDA PTV CATHETER VDA100184 manufactured by Bard Peripheral Vascular, Inc..
[5217035]
It was reported that post a successful pt valvuloplasty procedure a pericardial leak was diagnosed. The patient was sent to the operating room, btu expired during transit. The cause of death and relationship to the device is unknown at this time.
Patient Sequence No: 1, Text Type: D, B5
[12673270]
A manufacturing review could not be performed as the lot number is unknown. The device was not returned for evaluation; therefore, the investigation is inconclusive. The definitive root cause could not be determined based upon the available information. The relationship of the device to the death is unknown. It is unknown if patient and/or procedural issues contributed to the reported event.
Patient Sequence No: 1, Text Type: N, H10
[27431983]
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. This file indicated attempts were made to the facility to obtain information pertaining to 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). However, an explanation of missing information was not submitted to the fda. 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 | 2020394-2014-00551 |
| MDR Report Key | 4345684 |
| Report Source | 07,COMPANY REPRESENTATIVE,HEA |
| Date Received | 2014-12-10 |
| Date of Report | 2014-11-11 |
| Date of Event | 2014-11-10 |
| Date Mfgr Received | 2015-09-09 |
| Date Added to Maude | 2014-12-22 |
| 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 | 2014-12-10 |
| Catalog Number | VDA100184 |
| Lot Number | UNK |
| 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. Death | 2014-12-10 |