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

Catalog Number UNK NC TREK

Device Problems Entrapment of Device (1212); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2020

Event Type  Injury  

Manufacturer Narrative

The unique device identifier (udi) is unknown because the part and lot numbers were not provided.The product was not returned to abbott vascular for analysis.A review of the electronic lot history record (elhr), corrective action tracking system for the web (catsweb) database review and similar incident query was not performed since the lot number was not reported and the device was not returned for analysis.In this case, the device was prepped prior to use and inflated once prior to the balloon rupture without any leaks or ruptures noted.The investigation determined the reported balloon rupture and entrapment of the device appear to be related to operational circumstances of the procedure.Based on the reported information, during the second inflation, the balloon ruptured at 16 atmospheres.It is likely that during the second inflation the balloon became damaged against the previously implanted stent resulting in the reported balloon rupture.The ruptured balloon did not properly refold and became tangled with the stent.Additionally, the treatment appears to be related to the operational context of the procedure as the patient was taken to surgery to remove the device.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was performed to treat a lesion in the mid right coronary artery (rca).An unspecified stent was implanted and post dilatation was performed using an nc trek dilatation catheter.During the second inflation, the balloon ruptured at 16 atmospheres.The ruptured balloon became tangled with the newly implanted stent.The nc trek could not be removed.The patient was taken for a surgical removal of the device.Post procedure, the patient was in stable condition.No additional information was provided.

• Brand Name: NC TREK CORONARY DILATATION CATHETER
• Type of Device: 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: 10635522
• MDR Text Key: 210009012
• Report Number: 2024168-2020-08293
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK NC TREK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR