MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number 1012276-15

Device Problems Difficult to Remove (1528); Failure to Advance (2524)

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

Event Date 06/08/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a heavily calcified, heavily tortuous, 90% stenosed lesion in the mid right coronary artery (mrca).A 3.5x15mm trek rx balloon dilatation catheter (bdc) was advanced with resistance from the anatomy and could not cross to reach the target lesion.The bdc was removed with resistance from the anatomy and the procedure rescheduled.A rotablation procedure is planned for a future date.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

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 determined the reported complaints appear to be related to operational context.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: 14881835
• MDR Text Key: 295902306
• Report Number: 2024168-2022-07127
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138577
• UDI-Public: 08717648138577
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 1012276-15
• Device Catalogue Number: 1012276-15
• Device Lot Number: 91206G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2019
• 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