MAUDE Adverse Event Report: ABBOTT VASCULAR INC. MINI TREK¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	1012403-12A
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
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 the 2.0x12mm otw mini trek balloon dilatation catheter (bdc) was defective prior to use.The balloon was inflated to 4 atmospheres when it was noted the balloon had ruptured.There was no clinically significant delay in the procedure and no patient involvement.No additional information was provided.
Additional Manufacturer Narrative
Visual, functional and sem analysis were performed on the returned device.The reported complaint was confirmed.The production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.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.Based on the reported information and results of the complaint investigation there is no indication the reported balloon rupture is related to a potential product quality issue.Balloon material ruptures can be affected by numerous factors including, but not limited to, balloon damage during processing of the balloon material, insufficient preparation, or inflation technique.In this case, a conclusive cause for the reported balloon rupture could not be determined.Return device analysis noted radially peeled balloon material, tearing, and radially peeled flaps of balloon material on the balloon fold of the returned device.Although, the account stated that the device was soaked during preparation, in this case, it is possible that insufficient prep (soaking of the balloon) contributed to the reported balloon rupture based on the condition of the returned device; however, a conclusive cause cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D4 - model # correction: from na to 1012403-12a.

• Brand Name: MINI TREK¿
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 19237986
• Report Number: 2024168-2024-05443
• Device Sequence Number: 12797718
• Product Code: LOX
• UDI-Device Identifier: 08717648180873
• UDI-Public: (01)08717648180873(17)251231(10)30104G1
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123279
• 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): 10/01/2024

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: 12/31/2025
• Device Model Number: 1012403-12A
• Device Catalogue Number: 1012403-12A
• Device Lot Number: 30104G1
• 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: 04/18/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2023
• 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