MAUDE Adverse Event Report: ABBOTT VASCULAR NC TREK CORONARY DILATATION CATHETER

Model Number	1012454-15
Medical Device Problem Codes	Failure to Fold (1255); Off-Label Use (1494); Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not returning for evaluation, as it is retained by the account.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the tibial artery.An emboshield nav6 filter was advanced without issues.A 4.5x15mm nc trek rx balloon dilatation catheter (bdc) was advanced over the nav6 wire to post-dilate an unspecified deployed stent; however, the balloon did not rewrap well and could not be removed due to resistance with the anatomy.There was no deflation issue.While attempting to remove the bdc the shaft separated.An aspiration catheter was advanced to help remove the separated bdc.The separated bdc was successfully removed with the aspiration catheter and nav6 filter.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to filing the initial report, user facility medwatch report received states: "despite the balloon being fully deflated, there was great difficulty removing it.Despite careful manipulation, the shaft broke, with the balloon itself and part of the shaft remaining on the emboshield bare wire above the stent, and well above the distal embolic protection system.The doctor was able to recover the balloon and filter by using a ct 7 lightening thrombectomy system.".
Additional Manufacturer Narrative
H6: medical device problem code 1494 - incorrect anatomy.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.It was reported that the procedure was to treat a lesion in the tibial artery.It should be noted that the coronary dilatation catheters, nc trek rx, instructions for use (ifu) states: the nc trek rx coronary dilatation catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation.In this case, it is unknown if the ifu deviation caused or contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported failure to fold (winged balloon); however, the reported difficulty removing the device, separation, removal of foreign body and unexpected medical intervention appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.Attachment: user facility medwatch report # mw5112188na.

• Brand Name: NC 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: 15547504
• Report Number: 2024168-2022-10367
• Device Sequence Number: 1919299
• Product Code: LOX
• UDI-Device Identifier: 08717648152115
• UDI-Public: 08717648152115
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K103153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2022

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: 05/31/2025
• Device Model Number: 1012454-15
• Device Catalogue Number: 1012454-15
• Device Lot Number: 20620G1
• 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: 09/14/2022
• Supplement Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EMBOLIC PROTECTION SYSTEM: EMBOSHIELD NAV6
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male