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

Catalog Number 1013071-15

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide wire: sion, guide catheter: heartrail.Against resistance; excessive force.The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The traveler rx is currently not commercially available in the us; however, it is similar to a device sold in the us.

Event Description

It was reported that during a procedure of the non-tortuous, non-calcified, 90% stenosed, de novo, left main artery, the 3.5 x 15 mm traveler balloon dilatation catheter (bdc) was used for pre-dilatation at 12 atmosphere (atm), without issue.During removal, resistance was met with the lesion and the guide catheter.Force was applied and the distal portion separated.The complete device was removed with the guide catheter as a single unit.There was no reported adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual and scanning electron microscopy (sem) inspection and analysis were performed on the returned device.The reported separation was confirmed; however, the reported difficulty removing the device from the anatomy could not be replicated in a testing environment as that is based on operational circumstances.The reported difficulty removing the device from the guiding catheter could not be replicated in a testing environment due to the condition of the returned device.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 incidents from this lot.The traveler rx coronary dilatation catheters (cdc), instruction for use (ifu) states that if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.It is likely that the violation of the ifu contributed to the reported separation as the device separated after force was applied; however, the force was required to remove the device given the clinical situation.The investigation was unable to determine a conclusive cause for the reported difficulty removing the device from the anatomy and guiding catheter; however, the reported separation appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• 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: 7283492
• MDR Text Key: 100661620
• Report Number: 2024168-2018-01242
• 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,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• 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: 1013071-15
• Device Lot Number: 50918G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2018
• 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