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

Catalog Number 1013155-20

Device Problems Kinked (1339); Difficult to Remove (1528)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2016

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 device is currently not commercially available in the us; however, it is similar to a device sold in the us.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that a 3.50x20mm nc traveler balloon dilatation catheter (bdc) was removed from the dispenser coil and an attempt to remove the protective sheath was made; however, the sheath was tight and it could not be removed.The procedure was successfully completed with a 3.5x20mm nc traveler bdc.After the procedure another attempt was made to remove the protective sheath with force and the sheath was able to be removed.It was noticed that the hub was kinked but it was stated that this is probably due to the handling during preparation.There was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis and the reported resistance to remove the balloon protective sheath was confirmed.The inner diameter of the sheath met specification.The reported kink was confirmed.Based on an expanded investigation and further review of the complaint handling database and other sources of nonconformity data, it was determined that the device's performance with regards to the difficulty with removing the protective sheath appear to be related to normal variation found in manufacturing.The performance of these devices will continue to be monitored.

• 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: 6192004
• MDR Text Key: 63210262
• Report Number: 2024168-2016-09086
• Device Sequence Number: 1
• Product Code: LOX
• 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,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 1013155-20
• Device Lot Number: 50525G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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