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

Model Number 1012453-12

Device Problems Material Rupture (1546); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported the device is not returning. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a de novo, 90% stenosed lesion in the moderately calcified, mildly tortuous mid right coronary artery (mrca). An unspecified guide wire crossed and pre-dilatation was performed with a 4. 0x12 mm nc trek balloon dilatation catheter (bdc); however, the balloon ruptured at 8 atmospheres. There was resistance noted, likely with the lesion, during advancement. The bdc was removed without resistance and the rupture was confirmed outside the anatomy. A non-abbott bdc was used to continue pre-dilatation and a 4. 0x12 mm xience skypoint stent was deployed. Post dilatation was performed with a 4. 5x8 mm nc trek bdc. There were no adverse patient effects and there was no reported clinically significant delay in the procedure. No additional information was provided.

• 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
• 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: 12325475
• MDR Text Key: 266690568
• Report Number: 2024168-2021-07183
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 1012453-12
• Device Catalogue Number: 1012453-12
• Device Lot Number: 01005G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial