MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Catalog Number	1012276-15
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat acute coronary syndrome (acs) in the right coronary artery with moderate calcification, mild tortuosity and thrombus in the area.Pre-dilatation was performed with the 3.5x15 mm trek balloon dilatation catheter (bdc) and at some unknown point the tip of the bdc separated.There was no resistance during advancement or removal.The tip was embedded into the vessel wall with a drug eluting stent.There were no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
A 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 similar incidents and/or complaints from this lot.The investigation determined the reported separation, device embedded in tissue or plaque and unexpected medical intervention appear to be related to circumstance of the procedure.Factors that may contribute to a balloon separation may include, but not limited to, manufacturing damage, interaction with the anatomy, user attempts to remove against resistance and physician applies excessive force against resistance.Returned device analysis noted that the material at the noted shaft separation was stretched and jagged which suggests that the separation may be related to tensile overload (material stress/fatigue).In this case, it is likely that the bdc interacted with the patient anatomy and/or accessory device which resulted in tensile overload and upon manipulation of the device during removal the bdc ultimately separated.Additional treatment with a stent was performed to embed the separated portion into the vessel.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
• Common Device Name: 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: 18004230
• Report Number: 2024168-2023-11839
• Device Sequence Number: 15377657
• Product Code: LOX
• UDI-Device Identifier: 08717648138577
• UDI-Public: 08717648138577
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K103110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Catalogue Number: 1012276-15
• Device Lot Number: 21212G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 10/25/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BMW GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown