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

Catalog Number 1013067-15

Device Problems Material Separation (1562); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/31/2018

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 device is currently not commercially available in the us; however, it is similar to a device sold in the us.Evaluation summary: visual, dimensional and functional inspections were performed.The reported shaft separation and kink were confirmed.The reported difficulty positioning the device over the guide wire was not confirmed.The reported difficulty positioning the device in the guiding catheter could not be replicated in a testing environment due to the condition of the returned device.The reported failure to advance could not be replicated in a testing environment as it was based on operational circumstances.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulties appear 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.

Event Description

It was reported that the procedure was to treat a mildly tortuous, eccentric mid right coronary artery.During advancement of a 2.50x15mm traveler rx balloon dilatation catheter (bdc) for predilatation, it became kinked and the hypotube became separated.Resistance was felt with the anatomy and both the guide catheter and guide wire during advancement.Another same size device was used to successfully complete the procedure.There were no adverse patient effects 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: 8461491
• MDR Text Key: 140323813
• Report Number: 2024168-2019-02397
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 1013067-15
• Device Lot Number: 80627G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2018
• 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 Age: 51 YR
• Patient Weight: 76