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

Model Number	1012276-20
Medical Device Problem Codes	Deflation Problem (1149); Failure to Fold (1255)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
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 that the procedure was to treat a lesion in an unspecified artery.The 3.5x20mm trek balloon dilatation catheter (bdc) was used in a procedure and the balloon was noted to have an issue re-wrapping; however, the balloon eventually able to be deflated.The bdc was removed from the patient.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual, dimensional, and functional inspection was performed on the returned device.The reported deflation problem and failure to fold was confirmed.A review of the production records and corrective or preventive actions (capa) was performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.It was reported that the balloon dilation catheter had issues during deflation and refolding.Analysis of the returned balloon noted stretching of the inner member, outer member, and guide wire exit notch.This type of damage is consistent with manipulation against resistance and could impact the flow of saline mixture through the device.It is likely that the balloon dilation catheter (bdc) sustained damage during the procedure which impacted its ability to deflate and refold.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: 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: 19354761
• Report Number: 2024168-2024-06127
• Device Sequence Number: 7466625
• Product Code: LOX
• UDI-Device Identifier: 08717648138584
• UDI-Public: (01)08717648138584(17)260131(10)30216G1
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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: 01/31/2026
• Device Model Number: 1012276-20
• Device Catalogue Number: 1012276-20
• Device Lot Number: 30216G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• 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