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

Catalog Number 1012270-20T

Device Problems Detachment Of Device Component (1104); Kinked (1339)

Patient Problem No Patient Involvement (2645)

Event Date 11/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The tenku balloon dilation catheter device is an abbott vascular manufactured device which is distributed in (b)(4) by st.Jude medical (b)(4).Though this device is not commercially available for sale in the u.S, it is similar to a device currently marketed for sale in the u.S.Evaluation summary: visual inspection was performed on the returned device.The hypotube was separated distal to the strain relief tubing.The reported kink was not confirmed; however, it is likely that the kink reported was located at the separated location.In this case, it is possible that the device was inadvertently mishandled during unpackaging such that the device kinked.Kinks or bends in the hypotube can lead to weakening of the hypotube material such that subsequent application of force or further handling can cause a separation.Furthermore, it is likely that the shaft separated at the kink location due to handling during packaging for return of the device to abbott vascular.The investigation was determined that the reported kink appears to be related to circumstances of the procedure.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 similar incidents from this lot.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 during preparation and before use, when removing the tenku rx balloon dilatation catheter from the dispenser coil, the shaft was kinked.The device was not used in the patient and there was no patient involvement.No additional information was provided.Returned device analysis revealed a hypotube separation.

• Brand Name: TENKU 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: 6251161
• MDR Text Key: 65203618
• Report Number: 2024168-2017-00446
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 04544881151902
• UDI-Public: (01)04544881151902(17)180331(10)50406G1
• 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,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: 1012270-20T
• Device Lot Number: 50406G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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