MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2010-06-04 for ADVANCE 18 LP LOW PROFILE BALLOON DILATATION CATHETER PTA4-18-135-4-8 manufactured by Cook, Inc..
[1509811]
The dr wanted to post dilate a self expanding stent that he placed in the artery with a low profile balloon. He placed the balloon over a. 018" roadrunner wire and successfully crossed the lesion. He hand inflated the balloon, however, the balloon had ruptured; possibly due to the fact that the artery was heavily calcified. He took the wire out to inject some contrast and then went to put the wire back in, but couldn't get the wire across the lesion. He therefore took the wire and balloon out together and noticed that the actual balloon had come away from the catheter and that the wire was going through the side of the catheter and not the endhole as it is supposed to. Please note that the dr previously had tried to post inflate the stent with two other balloons and these also ruptured. Add'l info received 10/05/2010: the two add'l balloons that also ruptured were non cook devices. The procedure was eventually completed using a non cook device. No harm to pt reported.
Patient Sequence No: 1, Text Type: D, B5
[8554343]
(b)(4). No product or images were returned to assist in this investigation. Per dfmea (design failure modes and effect analysis): balloon burst, compliance, and fatigue verification testing performed. The rated burst pressure (14 atm) is documented in the ifu and label. The device is inspected per qc to ensure bonds and balloon are undamaged. Each device is leak tested. Each device is shipped with an instructions for use (ifu) that delineates the proper inflation and deflation procedures. The complaint correspondence indicates that the physician was treating a heavily calcified lesion. The calcification likely contributed to the rupture as an add'l two non-cook devices were used and ruptured as well. There was no indication that a pressure gauge was used to inflate. The inflation pressures were not reported. The physician decided to remove the wire guide to inject contrast and had difficulty reinserting. It is reasonable to suggest that once the physician lost the access, it was difficult to cross again as the lesion was heavily calcified and the balloon had ruptured. This resulted in the wire puncturing the catheter shaft. The device was removed and complaint correspondence indicated a circumferential rupture, which could be expected if the balloon is highly constricted. The complaint will be updated if the device is returned. Complaint will be trended as negligible harm as no harm to the pt was reported. We will notify the appropriate internal personnel of the event and continue to monitor for similar complaints.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2010-00253 |
| MDR Report Key | 1719769 |
| Report Source | 01,08 |
| Date Received | 2010-06-04 |
| Date of Report | 2010-05-07 |
| Date of Event | 2010-05-06 |
| Date Facility Aware | 2010-05-06 |
| Report Date | 2010-05-07 |
| Date Mfgr Received | 2010-05-11 |
| Device Manufacturer Date | 2009-09-25 |
| Date Added to Maude | 2010-08-28 |
| 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 | RITA HARDEN, MGR. |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANCE 18 LP LOW PROFILE BALLOON DILATATION CATHETER |
| Generic Name | KCG DILATOR, TRACHEAL |
| Product Code | KCG |
| Date Received | 2010-06-04 |
| Model Number | NA |
| Catalog Number | PTA4-18-135-4-8 |
| Lot Number | 2377646 |
| ID Number | NA |
| Device Expiration Date | 2012-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 8 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-04 |