MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012280-12
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.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 a right coronary artery with slight aneurysm altered with relative, slight stenosis to the outlet and complete thrombosis with subacute occlusion.A 5x12mm trek balloon was advanced and inflated at the three times at 10 atmospheres without issue.The balloon was completely deflated.However during withdrawal of the device, the balloon portion became detached from the catheter shaft and remained in the patient.The patient was transferred to cardiac surgery and aorto-coronary vein bypass grafting was performed and the balloon was successfully removed.Patient status is very good, as operation was uncomplicated and patient was discharged from the clinic after a week.There was a clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported separations were 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 was unable to determine a conclusive cause for the reported separations; however, the reported delay to treatment/therapy, surgical procedure, removal of foreign body and hospitalization appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a right coronary artery with slight aneurysm altered with relative, slight stenosis to the outlet and complete thrombosis with subacute occlusion.A 5x12mm trek balloon was advanced and inflated at the three times at 10 atmospheres without issue.The balloon was completely deflated.However during withdrawal of the device, the balloon portion became detached from the catheter shaft and remained in the patient.The patient was transferred to cardiac surgery and aorto-coronary vein bypass grafting was performed and the balloon was successfully removed.Patient status is very good, as operation was uncomplicated and patient was discharged from the clinic after a week.There was a clinically significant delay reported.Subsequent to the initially filed mdr report, the account confirmed device analysis that noted the inner and outer members being separated (1.6cm distal to the guide wire exit notch).Additionally, the account also confirms that the separated portions were successfully removed and discarded.No additional information was provided.

• 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: 14416192
• Report Number: 2024168-2022-05283
• Device Sequence Number: 5607416
• Product Code: LOX
• UDI-Device Identifier: 08717648138775
• UDI-Public: 08717648138775
• 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): 06/17/2022

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: 12/31/2022
• Device Model Number: 1012280-12
• Device Catalogue Number: 1012280-12
• Device Lot Number: 00106G1
• 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: 05/02/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 05/17/2022
• Supplement Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2020
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown