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

Model Number	1012454-20
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is expected to be returned for investigation.It has not yet been received.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 heavily calcified lesion in the right coronary artery.A 4.0x38mm xience sierra stent and a 4.0x18mm xience sierra stent were deployed successfully without issues.Routine post-dilatation was being performed with a 4.50x20mm nc trek rx balloon dilatation catheter (bdc); however, the balloon ruptured at 15 atmospheres.The bdc was being removed but resistance with the anatomy was felt.Force was applied to remove the bdc and it was noted that the distal shaft separated.At this time the bdc was removed as a unit with the guide wire and guide catheter and the separated distal shaft also came out.Imaging of the deployed stents was done and everything looked good.There were no adverse patient effects and 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 and complaint history of the reported device could not be conducted because the lot number was not provided.It should be noted that the coronary dilatation catheters, nc trek rx, global, instruction for use (ifu) states: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.In this case, it is likely that the violation of the ifu contributed to the reported separation as the device separated after force was applied.The investigation determined the reported balloon rupture and difficulty removing the device appears to be related to operational context; however, the reported shaft separation appears to be related to user error/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
• MDR Report Key: 11970433
• Report Number: 2024168-2021-04838
• Device Sequence Number: 17091191
• Product Code: LOX
• UDI-Device Identifier: 08717648152122
• UDI-Public: 08717648152122
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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 Model Number: 1012454-20
• Device Catalogue Number: 1012454-20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT: 4.0X18MM XIENCE SIERRA; STENT: 4.0X38MM XIENCE SIERRA
• Patient Age: 54 YR
• Patient Weight: 121