MAUDE Adverse Event Report: ABBOTT VASCULAR MINI TREK RX OTW LIMITED INDICATION; CORONARY DILATATION CATHETER

Model Number	1012403-08A
Medical Device Problem Codes	Off-Label Use (1494); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a fibrillation ablation procedure in the marshall vein, the 2.00x8mm mini trek ii balloon dilatation catheter (bdc) was advanced to the appropriate place and inflated when an unspecified 0.014 guide wire pierced the balloon.There was no reported adverse patient effect and no clinically significant delays in the procedure.Another same size minit trek balloon was used to successfully complete the procedure.No additional information was provided.
Additional Manufacturer Narrative
H6: medical device problem code 1494 clarifier- incorrect anatomy manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
The device was not retuned for evaluation.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.It was reported that the procedure was a fibrillation ablation procedure in the marshall vein.The instructions for use (ifu), indications section, states: the mini trek ii otw coronary dilatation catheter is indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion, balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction (mi), balloon dilatation of a stent after implantation (balloon models 2.00 mm only), balloon dilatation of de novo chronic total coronary occlusions (cto).In this case, it is unknown if the ifu violation contributed to the reported complaint because abbott has not evaluated this use.The investigation determined the reported complaint appears to be related to operational context.It was reported that during a fibrillation ablation procedure in the marshall vein, the 2.00x8mm mini trek ii balloon dilatation catheter (bdc) was advanced to the appropriate place and inflated when an unspecified 0.014 guide wire pierced the balloon.In this case, it is possible that the unspecified 0.014 guide wire was inadvertently mishandled and/or manipulated in such a way that it pierced through the balloon.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• Brand Name: MINI TREK RX OTW LIMITED INDICATION
• 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: 16747966
• Report Number: 2024168-2023-03845
• Device Sequence Number: 12918307
• Product Code: LOX
• UDI-Device Identifier: 08717648180866
• UDI-Public: 08717648180866
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110617
• 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): 07/28/2023

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: 05/31/2024
• Device Model Number: 1012403-08A
• Device Catalogue Number: 1012403-08A
• Device Lot Number: 10609G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2021
• 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
• Patient Sex: Unknown