MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Model Number	1012274-12
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); Embolism/Embolus (4438)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for evaluation; the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Patient id: (b)(6).It was reported that the procedure was performed to treat a lesion in the left peroneal artery.Pre-dilatation was performed with a 3.0 x 12 mm trek balloon dilatation catheter.The dilatation catheter balloon was inflated 1 time to 8 atmospheres and blood was noted in the balloon hub.During withdrawal of the device, the nc trek dilatation catheter balloon separated into several pieces that broke off the distal tip of the balloon.The fragments embolized to the distal peroneal artery and the superficial femoral artery (sfa).The fragments were removed with a snare device; however, a larger balloon fragment was stuck to the wall of the sfa and was covered with an absolute stent.Flow was restored to the peroneal and sfa.There was no additional information provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The reported patient effect of embolism is listed in the coronary dilatation catheters (cdc), trek rx global, instructions for use (ifu) as a known patient effect.The investigation was unable to determine a conclusive cause for the reported separations; however, the reported device embedded in tissue or plaque, additional treatment and removal of foreign body appear to be related to circumstances of the procedure.A conclusive cause for the reported embolism and the relationship to the device, if any, cannot be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.H6: medical device problem code 1546 removed.
Event or Problem Description
Subsequent to the initial report, additional information was received.It was reported that the trek dilatation catheter shaft fractured at the mid portion of the catheter.Both the guide wire exit port and the balloon were distal to the fracture, and due to the fracture, blood entered the hypotube and balloon.No additional information was provided.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Common Device Name: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• 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: 13254349
• Report Number: 2024168-2022-00491
• Device Sequence Number: 4431931
• Product Code: LOX
• UDI-Device Identifier: 08717648138423
• UDI-Public: 08717648138423
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2022

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: 07/31/2024
• Device Model Number: 1012274-12
• Device Catalogue Number: 1012274-12
• Device Lot Number: 10804G1
• 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: 12/20/2021
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2021
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American