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

Model Number	1012405-15
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion located in the left anterior descending coronary artery that was heavily calcified.The 2.5x15 mm trek otw balloon dilatation catheter (bdc) was used to treat the lesion.During removal, the shaft separated and a snare was used to successfully remove the device.No resistance was noted during advancement or withdrawal.It was noted that the separation may have been due to the patient anatomy as it was severely calcified.There were no reported adverse patient effects and no clinically significant delay in the procedure.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.
Additional Manufacturer Narrative
The device was not returned for evaluation.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.The investigation determined the reported separation and unexpected medical intervention appear to be related to operational context.There was no damage noted to the balloon dilatation catheter (bdc) during the inspection prior to use which suggests a product quality issue did not contribute to the reported difficulties.It was noted by the account that the separation may have been due to the patient anatomy as it was severely calcified.In this case, it is likely that the bdc was inadvertently mishandled during advancement such that the shaft became kinked and ultimately separated upon further manipulation during removal.Based on the reported information, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Additional information: d4 - model # added corrections: d1 - brand name updated d2a - common device name updated d3 - name updated d3 - address, city, postal code updated d9, h3: correction - it was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.

• 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: 18899298
• Report Number: 2024168-2024-03296
• Device Sequence Number: 7477371
• Product Code: LOX
• UDI-Device Identifier: 08717648153983
• UDI-Public: (01)08717648153983(17)260930(10)31018G2
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/27/2024

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 Expiration Date: 09/30/2026
• Device Model Number: 1012405-15
• Device Catalogue Number: 1012405-15
• Device Lot Number: 31018G2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 171 KG