MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK RX & VOYAGER NC; CORONARY DILATATION CATHETER

Model Number 1012454-15

Device Problem Deflation Problem (1149)

Patient Problems Angina (1710); Occlusion (1984)

Event Date 05/05/2020

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported that the procedure was to treat a moderately tortuous, mildly calcified de novo right coronary artery that was 80% stenosed.A 4.5x15mm nc trek balloon reached the lesion and was inflated once at 18 atmospheres but failed to deflate after post-dilatation.Patient experienced chest pain due to no flow noted.The balloon was able to be intentionally burst and the entire system was removed.It is not known how the physician burst the balloon.No new device was used to further treat the patient.There was no adverse patient sequela or clinically significant delay reported.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported deflation problem was unable to be replicated in a testing environment due to the condition of the returned device.A review of the lot history record identified one manufacturing nonconformity 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 reported patient effects of angina and occlusion are listed in the nc trek rx coronary dilatation catheter instructions for use as known patient effects of coronary procedures.The complaint investigation determined the reported deflation problem is related to a potential manufacturing issue associated with deflation issues.The reported difficulties possibly contributed to the reported patient effects; however a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• Brand Name: NC TREK RX & VOYAGER NC
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10078505
• MDR Text Key: 191676154
• Report Number: 2024168-2020-04448
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152115
• UDI-Public: 08717648152115
• Combination Product (y/n): N
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 1012454-15
• Device Catalogue Number: 1012454-15
• Device Lot Number: 00116G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Date Manufacturer Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention