MAUDE Adverse Event Report: ABBOTT VASCULAR MINI TREK II OTW CORONARY DILATATION CATHETER

Catalog Number	1012403-08A
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that during preparation, the 2.0 x 8 mm mini trek ii balloon dilatation catheter (bdc) was inflated to 8 atm for an inflation test, but ruptured.Another balloon was used to complete the procedure.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the previously filed report, the balloon ruptured during the 1st inflation at 8 atmospheres.The hospital contact stated that the prep instructions were followed according to the instructions for use, however an inflation test was done during prep and the balloon was soaked in water in order to verify that the balloon can be used with ethanol for vein of marshall ethanol infusion.2017- incorrect prep coding added since they inflated the balloon during prep.
Additional Manufacturer Narrative
Visual, functional and scanning electron microscopy (sem) analysis/inspection was performed on the returned device.The reported balloon rupture was 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 of the reported lot did not indicate a lot specific quality issue.It was reported by the account that the balloon was inflated and tested during preparation.It should be noted that the coronary dilatation catheters (cdc), mini trek ii over the wire (otw), global, information for use (ifu) states: remove all air from the syringe or inflation device barrel.Reconnect the syringe or inflation device to the inflation port of the dilatation catheter.Maintain negative pressure on the balloon until air no longer returns to the device.Slowly release the device pressure to neutral.In this case, it is unknown if the ifu violation caused or contributed to the reported complaint.Additionally, it was reported that the procedure was to treat an ablation of the marshall vein.The ifu 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.The investigation was unable to determine a conclusive cause for the reported balloon rupture.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• Brand Name: MINI TREK II OTW 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: 18636443
• Report Number: 2024168-2024-01375
• Device Sequence Number: 7763423
• Product Code: LOX
• UDI-Device Identifier: 08717648180866
• UDI-Public: (01)08717648180866(17)260731(10)30817G1
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

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: 07/31/2026
• Device Catalogue Number: 1012403-08A
• Device Lot Number: 30817G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2023
• 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