MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number 1012272-12

Device Problem Material Separation (1562)

Patient Problem Vascular Dissection (3160)

Event Date 01/21/2022

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a 95% stenosed vessel in the mid to distal left anterior descending (lad) artery and a 100% stenosed vessel in the obtuse marginal (om) artery.The 2.5x12mm trek rx balloon dilatation catheter (bdc) had no resistance during advancement and the balloon was inflated twice at an unspecified pressure for each inflation.Upon removal of the balloon catheter after the second inflation and imaging, it was noticed to have a short shaft and the balloon was left in the aorta.The separated portion was retrieved using multiple snare devices.Images of the lad revealed a dissection in the mid area and an additional stent was implanted to treat the dissection.There was no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

Visual inspection was performed on the returned device.The reported separation was confirmed.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/complaints from this lot.The investigation determined the reported separation, removal of foreign body and additional treatment appears to be related to operational context.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: 13502022
• MDR Text Key: 288306619
• Report Number: 2024168-2022-01371
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138287
• UDI-Public: 08717648138287
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1012272-12
• Device Catalogue Number: 1012272-12
• Device Lot Number: 11021G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 59 KG