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

Model Number	1012451-12
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
T was reported that the procedure was to treat a 90% stenosed, mildly calcified vessel without tortuosity in the mid right coronary artery (mrca).After a 3.5mm drug eluting stent was deployed in the mrca, there was malapposition at the proximal edge.The 3.5x12mm nc trek balloon dilatation catheter (bdc) was used for post-dilatation.However, the balloon ruptured during the first inflation at 12atm for 10 seconds.Prior to use, the catheter was soaked in saline and was prepared (air aspiration) inside the anatomy.There was no resistance when the protective sheath was removed and there was no resistance during advancement.There was resistance with a guide catheter during removal.A non-abbott balloon was used to complete the procedure.There was no adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.
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
It was reported that the procedure was to treat a 90% stenosed, mildly calcified vessel without tortuosity in the mid right coronary artery (mrca).After a 3.5mm drug eluting stent was deployed in the mrca, there was malapposition at the proximal edge.The 3.5x12mm nc trek balloon dilatation catheter (bdc) was used for post-dilatation.However, the balloon ruptured during the first inflation at 12atm for 10 seconds.Prior to use, the catheter was soaked in saline and was prepared (air aspiration) inside the anatomy.There was no resistance when the protective sheath was removed and there was no resistance during advancement.There was resistance with a guide catheter during removal.A non-abbott balloon was used to complete the procedure.There was no adverse patient effect.There was no reported clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: there was resistance with the guide catheter during removal but the nc trek bdc was removed independently.There was no clinically significant delay in the procedure.No additional information was 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 investigation determined the reported complaints appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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: 14886425
• Report Number: 2024168-2022-07141
• Device Sequence Number: 5162857
• Product Code: LOX
• UDI-Device Identifier: 08717648151972
• UDI-Public: 08717648151972
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: 1012451-12
• Device Catalogue Number: 1012451-12
• Device Lot Number: 11215G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDING CATHETER
• Patient Sex: Unknown