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

Catalog Number 1013063-06

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The traveler rx is currently not commercially available in the u.S.However, it is similar to a device sold in the us.The device was received.The investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported the procedure was to treat a lesion with 99% stenosis in the distal right coronary artery (rca).The lesion was dilated with a 1.2 x 6 mm rx traveler balloon catheter.The traveler balloon catheter was noted to have the balloon single marker not located in center, but distal while being inflated for the first time.The balloon marker appeared to be located slightly distal, the marker did not shift or move.There was no difficulty positioning the balloon due to the balloon marker issue.The balloon was inflated multiple times without any issues.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: TRAVELER RX 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: 5790489
• MDR Text Key: 49448896
• Report Number: 2024168-2016-04526
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103110
• 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
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 1013063-06
• Device Lot Number: 50918G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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
• Treatment: GUIDE WIRE: ATHLETE JOKER