MAUDE Adverse Event Report: AV-TEMECULA-CT NC TRAVELER CORONARY DILATATION CATHETER

Catalog Number 1013158-08

Device Problems Difficult to Remove (1528); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The nc traveler is currently not commercially available in the us; however, it is similar to a device sold in the u.S.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 from this lot.It should be noted that the coronary dilatation catheters (cdc), nc traveler rx, global, costa rica, instruction for use states: with 4.5 mm and 5.0 mm balloon dilatation catheters, some increased resistance may be noted upon insertion or withdrawal into or out of the guiding catheter.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a mildly tortuous, heavily calcified, eccentric, de novo, 90% stenosed lesion in the proximal right coronary artery.A non-abbott stent was deployed.The lesion was post-dilated with the nc traveler 4.50 x 8 mm at 18 atmospheres twice and then the nc traveler balloon was deflated.An attempt was made to remove the nc traveler but it got entangled with the guiding catheter.The entire system was removed from the anatomy and the procedure was completed.The balloon deflated flat and was not properly rewrapped.There were no adverse patient effects and no 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): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6660092
• MDR Text Key: 78260083
• Report Number: 2024168-2017-05261
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648196027
• UDI-Public: (01)08717648196027(17)180930(10)51015G1
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/22/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 1013158-08
• Device Lot Number: 51015G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2017
• Initial Date FDA Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• 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