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

Model Number	1012276-15
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was performed to treat a mildly calcified and heavily tortuous lesion in the proximal left circumflex.A 3.5x15mm trek rx balloon dilatation catheter (bdc) was attempted to be used for dilatation; however, the balloon was noted to rupture at 10atms.Therefore, the bdc was removed and an opstar imaging catheter was used to continue the procedure.There were no adverse patient effects nor clinically significant delay in procedure reported.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.
Event or Problem Description
It was reported that the procedure was performed to treat a mildly calcified and heavily tortuous lesion in the proximal left circumflex.After a 3.5x15mm trek rx balloon dilatation catheter (bdc) was prepared with no noted issues the bdc was attempted to be used for dilatation; however, the balloon was noted to rupture at 10atms.Therefore, the bdc was removed and an opstar imaging catheter was used to continue the procedure.There were no adverse patient effects nor clinically significant delay in procedure reported.Subsequent to filing the initial report, additional information was provided: the balloon was noted to rupture during the first inflation.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 received, the investigation determined that the reported balloon rupture appears to be related to operational context.There was no leak noted during preparation, which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is likely that the balloon interacted with the heavily tortuous and mildly calcified anatomy resulting in the reported balloon rupture during inflation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.B5 -procedure description was updated.

• 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 UNK ; CS UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 22142609
• Report Number: 2024168-2025-05703
• Device Sequence Number: 7276464
• Product Code: LOX
• UDI-Device Identifier: 08717648138577
• UDI-Public: (01)08717648138577(17)271031(10)41112G1
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K180040
• 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): 06/10/2025

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: 1012276-15
• Device Catalogue Number: 1012276-15
• Device Lot Number: 41112G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2024
• 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
• Patient Sex: Unknown