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

Model Number	1012276-20
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
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 to treat a lesion in the left anterior descending (lad) artery.The 3.5x20mm trek rx balloon dilatation catheter (bdc) shaft broke off inside the anatomy.It is unknown if intervention was performed to remove or embed the separated portion.Another balloon was used to complete the procedure.There was no adverse patient sequelae and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported separation was confirmed.The 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.Based on the reported information and results of the complaint investigation there is no indication the reported separation is related to a potential product quality issue.Possible factors that may contribute to a separation may include, but not limited to, interaction with the anatomy, user attempts to remove against resistance and physician applies excessive force against resistance.There was no damage noted to the device during the inspection prior to use or during preparation, which suggests a product quality issue did not contribute to the reported difficulties.Returned device analysis noted that the material at the noted inner and outer member separations was stretched and jagged which suggests that the separation may be related to tensile overload (material stress/fatigue).Based on the returned device, the noted stretching on the device and jagged material is indicative of difficulty and/or handling during removal which likely led to the reported separation; however, since limited information was provided, a conclusive cause cannot be determined.Additionally, foreign body in patient and serious injury/illness/impairment appear to be related to circumstances of the procedure.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: b5 describe event or problem: updated.D1 brand name updated.D2a common device name updated.D3 name updated.D3 address, city, postal code updated.
Event or Problem Description
Subsequent to filing the initial mdr, update to event description: it was reported that the procedure was to treat a lesion in the left anterior descending (lad) artery.The 3.5x20mm trek rx balloon dilatation catheter (bdc) shaft broke off inside the anatomy.It is unknown if intervention was performed to remove or embed the separated portion.There was no clinically significant delay in the procedure.Additionally, subsequent to the initially filed mdr, the following additional information was provided: another balloon was used to complete the procedure.No additional information was provided.

• 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: 19208962
• Report Number: 2024168-2024-05215
• Device Sequence Number: 7952143
• Product Code: LOX
• UDI-Device Identifier: 08717648138584
• UDI-Public: (01)08717648138584(17)260930(10)31004G1
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 07/22/2024

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: 1012276-20
• Device Catalogue Number: 1012276-20
• Device Lot Number: 31004G1
• 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: 04/15/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• 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: Disability
• Patient Sex: Unknown