MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-13 for TRUE DILATATION BALLOON 0204511 manufactured by Bard Peripheral Vascular, Inc..
[102239061]
Patient Sequence No: 1, Text Type: N, H10
[102239062]
The patient was taken to the cardiac catheterization lab for a transarterial aortic valve replacement (tavr). After placement of the aortic valve, post echocardiography with transesophageal echocardiography (tee) showed trace paravalvar regurgitation. The valve had a constricted appearance on fluoroscopy and the mean gradient across the valve measured at 17 mmhg. The procedure felt that this was too high of a gradient to leave and elected to proceed with balloon valvuloplasty. ? A 20 mm true balloon was used to dilate the valve. The balloon was taken to high pressure but ruptured during inflation. Unfortunately, there was significant resistance in retrieving the balloon back into the 14 fr sheath. The team attempted to bring the entire system out as a unit thinking that the balloon was not retrievable from the artery. With significant retraction on the system the balloon dissociated from the balloon catheter and became lodged in the external iliac artery. ? Several maneuvers were attempted to remove the balloon including upsizing to a 16fr sheath and snaring from the ipsilateral side and retrieval with a bioptome. Unfortunately the material appeared to be compressed in the external iliac artery and we could not retrieve it. ? A dsa was taken of the iliac system showing occlusion of the external iliac artery. ? The vascular surgery service was consulted. After discussions of potential options, the teams felt that surgical extraction of balloon material was going to be better option. The vascular surgeon performed surgical extraction of balloon material.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7333663 |
| MDR Report Key | 7333663 |
| Date Received | 2018-03-13 |
| Date of Report | 2018-03-08 |
| Date of Event | 2018-02-22 |
| Report Date | 2018-03-08 |
| Date Reported to FDA | 2018-03-08 |
| Date Reported to Mfgr | 2018-03-08 |
| Date Added to Maude | 2018-03-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRUE DILATATION BALLOON |
| Generic Name | BALLOON AORTIC VALVULOPLASTY |
| Product Code | OZT |
| Date Received | 2018-03-13 |
| Catalog Number | 0204511 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD PERIPHERAL VASCULAR, INC. |
| Manufacturer Address | 1625 WEST 3RD STREET TEMPE AZ 85281 US 85281 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2018-03-13 |