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

Catalog Number 1012449-15T

Device Problems Material Rupture (1546); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant products: guide wire: runthrough, rinato.Guide catheter: launcher ebu 3.5 mm.The nc tenku balloon dilation catheter is an abbott vascular manufactured device which is distributed in (b)(4).Although this device is not commercially available for sale in the us, it is similar to a device currently marketed for sale in the us.The device was not returned for evaluation.However, there was no leak noted during preparation prior to use or during the first two inflations, which suggests a product quality issue did not contribute to the reported difficulties.In this case it is likely that the balloon interacted with the mildly tortuous, moderately calcified and 90% stenosed lesion such that the balloon became damaged and subsequently ruptured during inflation.The same anatomical conditions likely contributed to the resistance met during advancement.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 incidents from this lot.The investigation determined the reported difficulty appears 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 lesion in the mildly tortuous, moderately calcified, 90% stenosed proximal left anterior descending coronary artery.A 3.00 x 15 mm nc tenku rx balloon dilatation catheter (bdc) was selected for post dilatation of a deployed stent.There were no issues noted with the bdc during unpacking, inspection and preparation.The bdc was advanced with a slight resistance felt to the lesion and upon the first inflation to 6 atmospheres the balloon ruptured.A non-abbott bdc was used to successfully complete the procedure.There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.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: 6201361
• MDR Text Key: 63534117
• Report Number: 2024168-2016-09208
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 04544881152091
• UDI-Public: (01)04544881152091(17)190430(10)60502G1
• 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
• Report Date: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 1012449-15T
• Device Lot Number: 60502G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• 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