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

Model Number 1012454-15

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 01/12/2021

Event Type  Injury  

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 Description

It was reported that the procedure was performed on (b)(6) 2021 to treat a lesion in the right coronary artery.A 4.0 mm xience stent was implanted.Post-dilatation was being performed as standard procedure with a 4.50 x 15 mm nc trek rx balloon dilatation catheter (bdc) and the balloon was inflated four times up to 22 atmospheres; however, the balloon was slow to deflate.However, in this case although the pressure dropped in the indeflator, the balloon did not deflate immediately.Contrast did clear after a combination of suction with luer lock syringe and traction to try and pull the balloon back to the guide catheter.The physician suspected the balloon had burst because the pressure dropped in the indeflator.The bdc was attempted to be removed but resistance was felt with the implanted stent and the guiding catheter and the balloon detached from the shaft.The patient was transferred to another facility and an unspecified drug eluting stent (des) was implanted and successfully apposed the balloon to the vessel wall.The patient had an uncomplicated discharge on (b)(6) 2021.No additional information was provided.

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.It should be noted the coronary dilatation catheters (cdc), nc trek rx, global, instruction for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).In this case, it is likely the combination of the ifu deviation and the previously implanted stents resulted in the reported balloon rupture.It was further reported that the balloon did not deflate immediately after the rupture.In this case, it is possible that the condition of the balloon rupture contributed to the slow deflation of the balloon; however, since the device was not returned for analysis, a conclusive cause cannot be determined.It is possible that since the balloon was slow to deflate that the balloon interacted with the previously implanted stent and guiding catheter resulting in the reported difficulty removing the device and the balloon ultimately separating.The investigation determined the reported balloon rupture appears to be related to user error/operational context; however, a conclusive cause for the reported deflation issue could not be determined.The reported difficulty removing the device from the stent, guiding catheter, balloon separation, patient effect of device embedded in vessel, additional treatment, therapy/non-surgical treatment/ delayed and hospitalization 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.D9, h3 device status changed from returning to not returned.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11304505
• MDR Text Key: 231174190
• Report Number: 2024168-2021-01028
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648152115
• UDI-Public: 08717648152115
• Combination Product (y/n): N
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 1012454-15
• Device Catalogue Number: 1012454-15
• Device Lot Number: 00615G1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention