MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012404-12
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
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 a heavily calcified lesion in the diagonal artery.The 2.25x12mm trek otw balloon dilatation catheter (bdc) was advanced to the target lesion without issue.During the first inflation at 6 atmospheres (atm), it was noticed that the balloon did not appear to be fully inflating.Negative pressure was applied, and during the second inflation at 8 atm, the balloon still did not appear to be fully inflating.The bdc was then removed and tested outside the patient.A small pinhole was observed on the distal end of the balloon and air was coming out.The patient did not need to be re-ballooned as the trek was able to dilate the lesion despite the balloon not fully inflating.The target lesion was treated, and the patient remained stable.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual, dimensional, functional and scanning electron microscopy (sem) inspections/analysis were performed on the returned device.The balloon was inflated when pressurized but lost pressure as fluid leaked out at the distal tip, confirming the reported inflation issue.There was no balloon rupture observed on the returned balloon catheter, thus the reported balloon rupture could not be confirmed.Although, a balloon rupture was not confirmed, it is likely that the noted leak in the device is what the account perceived as a rupture.Additionally, a tear was noted in the inner member.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 determined the balloon rupture appears to be related to operational context.A potential product quality issue was identified, based on the noted inner member damage, leak and confirmed inflation issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.

• 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: 12363080
• Report Number: 2024168-2021-07481
• Device Sequence Number: 3821603
• Product Code: LOX
• UDI-Device Identifier: 08717648153907
• UDI-Public: 08717648153907
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

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: 01/31/2024
• Device Model Number: 1012404-12
• Device Catalogue Number: 1012404-12
• Device Lot Number: 10222G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Initial Date Received by Manufacturer: 08/04/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1