MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012278-15
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Serious Injury
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 4.00x15 mm trek balloon dilatation catheter (bdc) did not cross the lesion due to the anatomy.The patient was treated with another trek bdc.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.The device was returned and device analysis identified a separated distal shaft and the separated portion was not returned.
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.H6 health effect - impact codes 2199, 4582 removed; 2687 added.
Event or Problem Description
It was reported that the 4.00x15 mm trek balloon dilatation catheter (bdc) did not cross the lesion due to the anatomy.The patient was treated with another trek bdc.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.The device was returned and returned device analysis identified a separated distal shaft and the separated portion was not returned.It is possible the distal shaft remains in the patient anatomy as follow-up with the site was not able to confirm the location of the device.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported failure to advance could not be replicated in a testing environment as it was based on operational circumstances.Additionally, return analysis noted a shaft separation, multiple kinks, stretching, wrinkles and corkscrew like material all over the inner, outer member and hypotube.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 of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported failure to advance appears to be related to circumstance of the procedure.The investigation was unable to determine a conclusive cause for the noted separation, multiple kinks, stretching, wrinkles and corkscrew like material all over the inner, outer member and hypotube and reported foreign body in patient.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.E1: name updated e3: occupation changed from physician to non-healthcare professional.

• 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: 13005731
• Report Number: 2024168-2021-11583
• Device Sequence Number: 16585818
• Product Code: LOX
• UDI-Device Identifier: 08717648138713
• UDI-Public: 08717648138713
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2022

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: 10/31/2023
• Device Model Number: 1012278-15
• Device Catalogue Number: 1012278-15
• Device Lot Number: 01102G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 01/04/2022; 01/27/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 01/24/2022; 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Sex: Male