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

Catalog Number 1013069-15

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant products: guide wire: versaturn, sion.Guide catheter: profit 6fr jl3.5.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 of the reported lot did not indicate a lot specific quality issue.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation determined the reported difficulty appear to be related to circumstances of the procedure.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 de novo concentric lesion in the proximal left anterior descending (lad) artery with mild tortuosity and heavy calcification that was 90% stenosed.Resistance was not felt during advancement of the 3.00 x 15mm traveler rx balloon dilatation catheter (bdc) through the lesion and it crossed successfully for pre-dilatation.The balloon ruptured during the first inflation at 6 atmospheres held for 15 seconds.A replacement bdc was used and the procedure was completed after a xience alpine stent was implanted.There were no adverse patient effects or clinically significant delay in the procedure reported.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: 6181663
• MDR Text Key: 62963500
• Report Number: 2024168-2016-08958
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648197031
• UDI-Public: (01)08717648197031(17)170630(10)40717G1
• 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: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 1013069-15
• Device Lot Number: 40717G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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: CONCOMITANT MEDICAL DEVICES