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

Catalog Number 1012272-12

Device Problems Detachment Of Device Component (1104); Kinked (1339); Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a lesion in the non-tortuous, non-calcified, mid right coronary artery (rca).A 2.50 x 12 mm trek rx balloon dilatation catheter (bdc) met resistance during advancement through the guiding catheter and would not go completely through.The proximal shaft of the bdc kinked and separated approximately 10 cm proximal to the 90 cm marker and the rest of the shaft was still in the guide catheter.An unspecified trapper balloon catheter was advanced into the guide catheter, inflated to trap the separated bdc shaft within the guide catheter and they were removed from the anatomy as a unit.At that point the right radial artery access site was lost.They changed the access site to the left radial artery and used a 2.5 x 15 mm non-abbott bdc to complete the procedure.Although there was a delay in the procedure, it is not considered to be clinically significant.There was no reported adverse patient sequela.No additional information provided.

Manufacturer Narrative

(b)(4) correction- device status changed from returning to not returned.The device was not returned for evaluation.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 kink and separation appear to be related to circumstances of the procedure; however, a conclusive cause could not be determined for the reported difficulty positioning the balloon dilatation catheter.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: TREK 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: 7335977
• MDR Text Key: 102305450
• Report Number: 2024168-2018-01782
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 1012272-12
• Device Lot Number: 71115G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• 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
• Patient Age: 67 YR
• Patient Weight: 60