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

Catalog Number 1012452-15T

Device Problems Difficult to Remove (1528); Stretched (1601); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 03/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The tenku balloon dilatation catheter is an abbott vascular manufactured device which is distributed in (b)(6) by (b)(4).Though this device is not commercially available for sale in the us, it is similar to a device currently marketed for sale in the us.

Event Description

It was reported that during preparation of the 3.75 x 15 mm nc tenku dilatation catheter, the protective sheath and stylet may have been difficult to remove.After removal, it was noted that the shaft was twisted and the balloon shoulder stretched.The device was not used and there was no patient involvement.A same size non-abbott dilatation catheter was used and the procedure was completed.There was no clinically significant delay.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: a visual and dimensional inspection was performed on the returned device.The reported twisted and stretched material was confirmed.The reported difficulty removing the protective sheath could not be tested as the protective sheath was not returned.The inner member was separated at the proximal balloon marker, but the balloon and the outer member were still intact.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 similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty removing the protective sheath.The reported twisted and stretched material appears to be related to the circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• Brand Name: NC 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: 5575692
• MDR Text Key: 43039636
• Report Number: 2024168-2016-02392
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K110134
• 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,Followup
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 1012452-15T
• Device Lot Number: 41002G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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