MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK CORONARY DILATATION CATHETER

Model Number 1012448-12

Device Problems Inflation Problem (1310); Leak/Splash (1354); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned for analysis. The reported inflation problem was able to be confirmed. Additionally during device analysis, it was noted that the outer member was stretched and the inner member was torn above the proximal seal. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other incidents from this lot. As there was no report of a leak during preparation for use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement interaction with the guide wire/other devices in conjunction with interaction with the heavily tortuous and mildly calcified lesion resulted in the noted torn inner member; thus resulting in the reported inflation problem/noted tip leak. Manipulation of the device resulted in the noted stretched and folded outer member. There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a heavily tortuous and mildly calcified lesion in the left circumflex artery. The 2. 75x12mm nc trek balloon catheter (bdc) was advanced. Several attempts to inflate the balloon to nominal pressure were made; however, balloon failed to inflate. Another 2. 75x12mm nc trek bdc was used to successfully complete the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. The returned device analysis identified that the outer member was stretched proximal to the proximal seal, the inner member above the proximal seal was torn, and fluid was observed coming out of the tip. No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10160534
• MDR Text Key: 195363802
• Report Number: 2024168-2020-05094
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial
• Report Date: 06/16/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1012448-12
• Device Catalogue Number: 1012448-12
• Device Lot Number: 90822G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial