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

Model Number	1012272-20
Medical Device Problem Codes	Failure to Fold (1255); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the procedure was to treat a lesion in the right coronary artery (rca).The 2.50x20mm rx trek balloon dilatation catheter (bdc) was used for dilatation and was inflated once to 12 atmospheres.After dilatation, the balloon was poorly folded and became stuck on the guide wire; therefore both devices were removed.The coronary guide wire was reimplanted and a new balloon catheter was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative 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.Based on the information provided, a definitive cause for the reported complaints could not be determined.In this case, it is possible that sufficient time was not allowed to fully deflate the balloon before an attempt was made to withdraw the device giving the impression of a winged balloon; however, this cannot be confirmed.Possible factors that may contribute to the difficult removing the guide wire causing resistance between the devices may include, but not limited to, manufacturing damage, inner diameter of guide wire lumen, condition of the guide wire, or damage to the distal shaft of the catheter.In this case, a conclusive cause for the reported complaints cannot be determined since the device or components were not returned for analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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: 20744816
• Report Number: 2024168-2024-13789
• Device Sequence Number: 8755965
• Product Code: LOX
• UDI-Device Identifier: 08717648138300
• UDI-Public: (01)08717648138300(17)270228(10)40325G1
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2024

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 Model Number: 1012272-20
• Device Catalogue Number: 1012272-20
• Device Lot Number: 40325G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE
• Patient Sex: Unknown