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

Catalog Number 1013063-06

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intimal Dissection (1333)

Event Date 08/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this event.A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined.The reported patient effect of intimal dissection is listed in the coronary dilatation catheters (cdc), traveler rx, global, costa rica, instruction for use as a known patient effect.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The traveler is currently not commercially available in the u.S.However, it is similar to a device sold in the us.

Event Description

It was reported that the procedure was to treat a lesion located in the moderately torturous, mildly calcified de novo distal right coronary artery.A 1.2 x 06 mm traveler balloon dilatation catheter (bdc) was advanced to the lesion for pre-dilatation.The bdc was inflated to 14 atmoshperes and a dissection occurred.An unspecified stent was implanted for treatment of the dissection.There was no adverse patient sequela.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: 7029851
• MDR Text Key: 92021818
• Report Number: 2024168-2017-08955
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 1013063-06
• Device Lot Number: 51030G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2017
• 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
• Patient Outcome(s): Required Intervention