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

Catalog Number 1012270-12T

Device Problems Deflation Problem (1149); Kinked (1339); Difficult to Remove (1528); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2016

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 dilation catheter device is an abbott vascular manufactured device which is distributed in (b)(4) by (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.

Event Description

It was reported that the procedure was to treat a moderately tortuous and heavily calcified lesion in the mid right coronary artery.A 2.0x12mm tenku rx balloon dilatation catheter (bdc) experienced difficulty crossing the calcified lesion; therefore, the bdc was advanced with the support of a guideliner.The bdc reached the lesion and was inflated to 14 atmospheres three times.The balloon deflated without issue after the first 2 inflations.After the third inflation negative pressure was pulled and the bdc was retracted; however, resistance was felt.The whole system was pulled as a single unit and once outside the anatomy it was confirmed that the balloon remained fully inflated.Additionally, it was noticed that the distal shaft was kinked.The lesion was successfully further dilated with a non-abbott balloon catheter.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.The reported kink was confirmed; however the deflation issue could not be replicated in a testing environment due to the condition of the returned device.The difficulty to remove and resistance complaints could not be replicated in a testing environment as they are based on operational circumstances.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 was unable to determine a conclusive cause for the reported deflation issue; however the reported kink, difficulty to remove and physical resistance 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.

• 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: 6179703
• MDR Text Key: 62702300
• Report Number: 2024168-2016-08947
• Device Sequence Number: 1
• Product Code: LOX
• 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,Followup
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 1012270-12T
• Device Lot Number: 51001G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• 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
• Treatment: GUIDE WIRE: RUNTHROUGH,SIONBLUEOTHER: GUIDELINER