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

Catalog Number	1012454-15
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2024
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 65% stenosed lesion in the ostial right coronary artery (rca).The 4.5x15mm nc trek balloon dilatation catheter (bdc) was used in the procedure for dilatation and the tip of the balloon broke off in the vessel.A snare device was used to attempt to remove the separated portion of the bdc; however, could not be removed.Therefore, the patient was transferred to vascular surgery and the separated portion of the bdc was removed in surgery.There was no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported separation was confirmed.The lot history record (elhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no other similar incidents and/or 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.In this case, although the account reported that there was no difficulty experienced during removal, 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.Additionally, the investigation determined the reported patient effects of unexpected medical intervention, surgical intervention and hospitalization appear to be related to circumstances of the procedure.Based on the reported information, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a 65% stenosed lesion in the ostial right coronary artery (rca).The 4.5x15mm nc trek balloon dilatation catheter (bdc) was used in the procedure for dilatation and the tip of the balloon broke off in the vessel.A snare device was used to attempt to remove the separated portion of the bdc; however, could not be removed.The patient was transferred to vascular surgery and the separated portion of the bdc was removed in surgery.There was no adverse patient sequela.No additional information was provided.

• Brand Name: NC TREK RX 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: 18743739
• Report Number: 2024168-2024-02103
• Device Sequence Number: 7243567
• Product Code: LOX
• UDI-Device Identifier: 08717648152115
• UDI-Public: (01)08717648152115(17)250731(10)20824G1
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2024

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: 07/31/2025
• Device Catalogue Number: 1012454-15
• Device Lot Number: 20824G1
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown