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

Model Number	1012274-12
Medical Device Problem Codes	Material Separation (1562); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the 3.0x12mm rx trek balloon dilatation catheter (bdc) was used in an unknown artery.The balloon was unable to deflate.The physician attempted to carefully remove the inflated balloon however it separated.The patient was transferred to another hospital to surgically remove the separated portion of the device.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.B3, b6: estimated date.
Event or Problem Description
It was reported the 3.0x12mm rx trek balloon dilatation catheter (bdc) was used in an unknown artery.The balloon was unable to deflate.The physician attempted to carefully remove the inflated balloon however it separated.The patient was transferred to another hospital to surgically remove the separated portion of the device.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported separation was confirmed.The reported failure to deflate could not be replicated in a testing environment due to the condition of the returned device.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 reported information and the observations from the returned analysis, a definitive cause for the reported failure to deflate could not be determined; however, the reported separation, surgical intervention and hospitalization appear to be related to circumstances of the procedure.Possible factors that may contribute to failure to deflate include, but are not limited to, deflation technique, tortuous anatomy, contrast concentration, contamination in the inflation lumen, or damage to the guide wire and/or inflation lumen.In this case, it is likely that since difficulty deflating the balloon was experienced, the shaft ultimately separated during attempts to remove it.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: 21054184
• Report Number: 2024168-2025-00007
• Device Sequence Number: 12957412
• Product Code: LOX
• UDI-Device Identifier: 08717648138423
• UDI-Public: (01)08717648138423(17)270531(10)40625G1
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 03/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1012274-12
• Device Catalogue Number: 1012274-12
• Device Lot Number: 40625G1
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown