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

Catalog Number 1012268-12

Device Problems Difficult to Remove (1528); Material Rupture (1546); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2021

Event Type  malfunction  

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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the 75% stenosed and heavily calcified artery during advancement causing the reported difficult to advance.It is likely the balloon was damaged due to the interaction with the difficult anatomy during advancement and/or due to interaction with the difficult anatomy during inflation causing the reported material rupture.Continued interaction with the difficult anatomy during removal likely caused the reported difficulty to remove.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 the right coronary artery (rca) with 75% stenosis and heavy calcification.The vessel diameter was 2.5 mm and the length was 30 mm.The 1.2x12 mm mini trek balloon dilatation catheter (bdc) was advanced and possibly became caught on calcification with the lesion.The bdc ruptured during the first inflation at an unknown pressure.There was resistance noted with the lesion during removal; however, the balloon was fully deflated.A non-abbott bdc was used to complete the procedure.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

• Brand Name: MINI 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: 12569539
• MDR Text Key: 274536210
• Report Number: 2024168-2021-08853
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 1012268-12
• Device Lot Number: 00831G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1