MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

Catalog Number	1012272-30
Medical Device Problem Codes	Off-Label Use (1494); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
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 peroneal artery in the lower leg with stenosis.The 2.5x30mm trek rx balloon dilatation catheter (bdc) was being advanced when the delivery catheter broke into two pieces.A snare device was used to retrieve the separated portion and nothing was left inside the anatomy.It was at the end of the procedure when the device separated and the procedure ended without using another balloon or device there was no reported adverse patient sequelae and there was no reported clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
It was reported that the procedure was to treat a lesion in an unspecified artery in the lower leg.The 2.5x30mm trek rx balloon dilatation catheter (bdc) was being advanced when the delivery catheter broke into two pieces.The separated portion was successfully removed from the anatomy.The type of intervention performed was unspecified.There was no reported adverse patient sequelae and there was no reported clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: the lesion treated was the peroneal artery with stenosis.A snare device was used to retrieve the separated portion and nothing was left inside the anatomy.It was at the end of the procedure when the device separated and the procedure ended without using another balloon or device.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported separation was confirmed.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 incidents complaints from this lot.It was reported that the procedure was to treat a lesion in the peroneal artery with stenosis in the lower leg.It should be noted that the cdc, trek rx and mini trek rx, global, instruction for use (ifu) states: the trek rx coronary dilatation catheters are indicated for: balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion, balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction, balloon dilatation of a stent after implantation.In this case, it is unknown if the ifu violation contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported separation.However, possible factors that may contribute to a balloon separation may include, but not limited to, manufacturing damage, interaction with the anatomy, user attempts to remove against resistance and physician applies excessive force against resistance.The product risk assessment identifies this as a foreseeable event; as such, design and manufacturing controls and mitigations have been established for potential causes.The investigation determined the reported unexpected medical intervention appears to be related to circumstance of the procedure.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: 1494 incorrect anatomy added.

• 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: 17557535
• Report Number: 2024168-2023-08885
• Device Sequence Number: 3626353
• Product Code: LOX
• UDI-Device Identifier: 08717648138324
• UDI-Public: 08717648138324
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 11/14/2023

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: 12/31/2025
• Device Catalogue Number: 1012272-30
• Device Lot Number: 30118G1
• 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: 07/27/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2023
• 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 Sex: Unknown