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

Catalog Number 1013155-08

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis. 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 from this lot. As the balloon deflated correctly after the first and second inflations, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that prior to the third deflation manipulation of the device resulted in compromising the outer member thereby reducing the inflation/deflation lumen thus resulting in the reported deflation problem. There is no indication of a product quality issue with respect to manufacture, design or labeling. The nc traveler is currently not commercially available in the u. S. ; however, it is similar to a device sold in the u. S.

Event Description

It was reported that the procedure was to treat a concentric, mildly tortuous, moderately calcified lesion in the distal right coronary artery. Following stent implantation, the 3. 50x8 mm nc traveler balloon dilatation catheter (bdc) was used for post-dilatation but failed to deflate after the third inflation. The balloon was inflated three times at 18 atmospheres, each for 10 seconds. Negative pressure was applied no less than 5 times and when the balloon deflated a little it was retrieved into the guiding catheter that was already present in the anatomy. A non-abbott bdc was used to complete the procedure. 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 TRAVELER 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: 11174750
• MDR Text Key: 227006478
• Report Number: 2024168-2021-00465
• 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,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/14/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 1013155-08
• Device Lot Number: 00107G1
• 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: 12/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial