MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012280-15
Medical Device Problem Codes	Failure to Fold (1255); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 main trunk.A 5x15mm trek balloon was not prepped (air aspiration) outside the anatomy prior to use.The device was advanced to the lesion and inflated once at 11 atmospheres for 10 seconds without issue.It took 2-3 seconds for the trek to deflate completely but it did not refold tightly back properly.During removal of the trek it kept getting stuck at the guiding catheter entrance.Therefore, the balloon and guide catheter were removed altogether as a single unit.There was no need for an additional balloon as the trek had completed what they needed for the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device and identified a leak coming from a tear on the outer member.The reported failure to fold (winged balloon) and difficulty removing the device 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 failure to fold (winged balloon); however, the reported difficulty removing the device from the guiding catheter appears to be related to operational context.Factors that may contribute to a non-uniform balloon refold (winged balloon) include, but not limited to, large balloon profile and deflation technique.It should be noted that the coronary dilatation catheters (cdc), trek rx and mini trek rx, global instructions for use, states: with 4.5 mm and 5.0 mm balloon dilatation catheters, some increased resistance may be noted upon insertion or withdrawal into or out of the guiding catheter.Choosing a larger guiding catheter size may minimize this.In this case, it is possible that the combination of the larger profile of the 5.00 mm balloon and the reported winged balloon contributed to the resistance met with the guiding catheter, resulting in the difficulty removing the bdc.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.Na.

• 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: 11267653
• Report Number: 2024168-2021-00798
• Device Sequence Number: 753764
• Product Code: LOX
• UDI-Device Identifier: 08717648138782
• UDI-Public: 08717648138782
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

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: 12/31/2022
• Device Model Number: 1012280-15
• Device Catalogue Number: 1012280-15
• Device Lot Number: 00106G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1