MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number 1012272-15

Device Problem Material Rupture (1546)

Patient Problem Vascular Dissection (3160)

Event Date 02/16/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat an 80% stenosed, moderately calcified and mildly tortuous vessel in the mid left anterior descending (lad) artery. During pre-dilatation, the 2. 5x15mm trek rx balloon dilatation catheter (bdc) had no resistance during advancement and was soaked prior to use and prepared (air aspiration) outside the anatomy. However, the bdc was inflated once and the balloon ruptured at 8 atmospheres (atms). A dissection occurred. Two unspecified stents (3. 0x28mm, 2. 5x38mm) were used to treat the dissection. There was no adverse patient sequela and there was no clinically significant delay in the procedure. No additional information was provided.

Manufacturer Narrative

The device was not returned for evaluation. 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 similar incidents and/or complaints from this lot. The investigation was unable to determine a conclusive cause for the reported balloon rupture. The reported patient effect of dissection is listed in the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instructions for use as a known patient effect. A conclusive cause for the reported patient effect of dissection and the relationship to the device, if any, cannot be determined. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: 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: 13715378
• MDR Text Key: 287190178
• Report Number: 2024168-2022-02418
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1012272-15
• Device Catalogue Number: 1012272-15
• Device Lot Number: 11022G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/09/2022 Patient Sequence Number: 1