MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012276-20
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for investigation.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 de novo, 90% stenosed, heavily calcified and heavily tortuous vessel in the left circumflex (lcx) artery.The 3.5x20mm nc trek balloon dilatation catheter (bdc) was advanced with resistance noted with the lesion.The trek bdc was used for pre-dilatation, however, the bdc separated at the distal portion before the balloon.There was some resistance with the anatomy during removal.The device was retrieved from the vessel with a balloon anchor.A 3.5x20mm non-abbott device was used to complete the procedure.There was no reported adverse patient sequela and there was no reported clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
It was reported that the procedure was to treat a de novo, 90% stenosed, heavily calcified and heavily tortuous vessel in the left circumflex (lcx) artery.The 3.5x20mm nc trek balloon dilatation catheter (bdc) was advanced with resistance noted with the lesion.The trek bdc was used for pre-dilatation, however, the bdc separated at the distal portion before the balloon.There was some resistance with the anatomy during removal.The device was retrieved from the vessel with a balloon anchor.A 3.5x20mm non-abbott device was used to complete the procedure.There was no reported adverse patient sequela and there was no reported clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported separation was confirmed.The reported difficulty advancing and removing the device from the anatomy could not be replicated in a testing environment as it was based on operational circumstances.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 complaints, additional treatment and removal of foreign body appear to be related to circumstance of the procedure.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
• MDR Report Key: 12487955
• Report Number: 2024168-2021-08244
• Device Sequence Number: 11600476
• Product Code: LOX
• UDI-Device Identifier: 08717648138584
• UDI-Public: 08717648138584
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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: 11/30/2023
• Device Model Number: 1012276-20
• Device Catalogue Number: 1012276-20
• Device Lot Number: 01201G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Initial Date Received by Manufacturer: 08/28/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention