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

Model Number 1012452-20

Device Problems Deflation Problem (1149); Failure to Fold (1255); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4). The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information. On january 15, 2020, the abbott vascular determined that a field safety corrective action is required for specific lots of nc trek rx coronary dilatation catheter, and nc traveler coronary dilatation catheter. The field safety action number is (b)(4). This action is being taken as a result of an increase in the complaint trend for reported failures of deflation for nc trek rx and nc traveler rx coronary dilatation catheter. Product from identified lots may exhibit slow, partial or failure to deflate.

Event Description

It was reported that during preparation of the 3. 75x20mm nc trek balloon dilatation catheter (bdc), difficulty was experienced in removing the protective sheath. The bdc was advanced to the 70% stenosed mid to proximal right coronary artery (rca) for post-dilatation. The bdc was inflated 3 times to 20 kilopascal-pressure-units (kpa), and negative was held for 5 seconds, but the balloon would not fully deflate, or refold tightly enough to be pulled back into the guiding catheter, so the guide wire, guide catheter, and partially deflated balloon were removed as a single unit. There was no adverse patient effect, or a clinically significant delay in the procedure. 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: 10680821
• MDR Text Key: 211486629
• Report Number: 2024168-2020-08600
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1012452-20
• Device Catalogue Number: 1012452-20
• Device Lot Number: 90922G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1133- 2020