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

Catalog Number 1012453-08T

Device Problems Difficult to Remove (1528); Material Rupture (1546); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation.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 of the reported lot did not indicate a lot specific quality issue.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.The tenku is not commercially available for sale in the u.S; however, it is similar to a device currently marketed for sale in the u.S.

Event Description

It was reported that the procedure was performed to treat an eccentric lesion in the proximal right coronary artery with mild tortuosity, mild calcification and 90% in-stent re-stenosis.A 4.00x8 mm nc tenku balloon dilatation catheter (bdc) was advanced to the lesion with resistance from the anatomy.The balloon ruptured on the first inflation at 6 atmospheres.Resistance with the anatomy was also noted during removal of the bdc.A 3.5mm non-abbott drug-coated balloon was used to complete dilatation and an unspecified stent was implanted.Post-dilatation was performed with a 4.5x8mm non-abbott bdc to successfully complete the procedure.There was no adverse patient effect and no reported clinically significant delay in the procedure.No additional information was provided.

• 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: 7643300
• MDR Text Key: 112561217
• Report Number: 2024168-2018-05084
• 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,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 1012453-08T
• Device Lot Number: 51203G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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