MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012274-25
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat the obtuse marginal coronary artery with mild tortuosity, moderate calcification and in stent restenosis.The patient had significant 3 vessel disease but they were not a candidate for bypass surgery.The 3.0x25 mm trek balloon dilatation catheter (bdc) was inflated once and deflated after use but during removal the balloon was lodged at the mouth of the guiding catheter.The balloon separated into two pieces.The balloon remained on the guide wire.The balloon and the catheter of the device were removed with the guide wire and guide catheter as a single unit.There was no replacement device.There were no adverse patient effects and there was no clinically significant delay in the procedure.The patient expired within 24 hours of (b)(6) 2022; however the cause of death was not provided and in the physician's opinion, the trek balloon did not cause or contribute to the death.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The material separation was confirmed.The difficult to remove cannot be tested in a lab environment, nor due to the condition of the device.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.The investigation could not determine the cause for the reported difficult to remove, and material separation.It is possible the balloon rewrap was sub-optimal causing resistance at the guide leading to the material separation, however, this cannot be confirmed.There is no indication of a product quality issue with respect 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: 15934845
• Report Number: 2024168-2022-12348
• Device Sequence Number: 20112855
• Product Code: LOX
• UDI-Device Identifier: 08717648138454
• UDI-Public: 08717648138454
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 1012274-25
• Device Catalogue Number: 1012274-25
• Device Lot Number: 00429G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/16/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2020
• 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
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 81 KG