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

Model Number	1012450-20
Medical Device Problem Codes	Material Rupture (1546); Difficult to Advance (2920)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.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.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the heavily calcified and tortuous anatomy resulting in the reported difficult to advance.Interaction with the heavily calcified anatomy/manipulation of the device resulted in compromising the balloon material; thus resulting in the reported material rupture.The reported difficulties possibly contributed to the reported patient effects, however, conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The treatment appears to be related to the operational context of the procedure.The reported patient effect of perforation is listed in the nc trek rx coronary dilatation catheter instructions for use as a known patient effect of coronary procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.The two additional devices (graftmasters) referenced are being filed under separate medwatch report numbers.
Event or Problem Description
It was reported that this was a percutaneous coronary intervention in the left anterior descending coronary artery (lad).The 3.25x20 mm nc trek balloon dilatation catheter (bdc) was advanced and met resistance with the heavily calcified and tortuous anatomy.The nc trek was inflated twice at 12 atmospheres of pressure.A perforation occurred in the lad after the balloon rupture.The 3.5x16 mm graftmaster stent delivery system (sds) was inserted, but it was unable to cross the vessel due to the patient anatomy.The 2.8x16 mm graftmaster sds was inserted and was successfully implanted; however, this 2.8x16 size was used after the labeled expiration date.The perforation was sealed.The patient has not had any adverse reactions to the expired graftmaster stent.This was used because it was the only unit available and it was a life threatening situation for the patient.No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10693492
• Report Number: 2024168-2020-08672
• Device Sequence Number: 3058511
• Product Code: LOX
• UDI-Device Identifier: 08717648151941
• UDI-Public: 08717648151941
• Combination Product (Y/N): N
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 1012450-20
• Device Catalogue Number: 1012450-20
• Device Lot Number: 90910G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Weight: 68