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

Catalog Number 1012450-15T

Device Problems Difficult To Position (1467); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant products: guide wire: glandslam.Guide catheter: launcher 6f ebu.The device is expected to be returned for evaluation.It has not yet been received.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 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 the procedure was to treat a moderately calcified, eccentric, de novo, 75% to 95% stenosed, 15mm-long lesion in the moderately tortuous, 2.5mm-diameter, proximal to the distal left circumflex (lcx) coronary artery.When advancing a 3.25x15 nc tenku rx balloon dilatation catheter (bdc) over the proximal end of a grandslam guide wire (gw), while still outside of the patient anatomy, resistance was felt between the two devices.The bdc with withdrawn from the gw with resistance felt and the gw was wiped with saline-soaked gauze.The bdc was then re-advanced over the gw, however, as the bdc was advanced into the coronary vessel, resistance increased.Thus, the uninflated bdc was retracted over the gw and out of the anatomy, with resistance felt against the proximal gw.The same guide wire was able to be used with a non-abbott bdc and a non-abbott stent delivery system without issue to complete the procedure.There were no adverse patient effects and no occurrence of a clinically significant delay.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.The reported resistance with the guide wire was not confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.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 difficulties as there was no resistance noted with the guide wire during returned analysis.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 6201094
• MDR Text Key: 63475782
• Report Number: 2024168-2016-09194
• 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: 02/07/2017

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: 12/31/2018
• Device Catalogue Number: 1012450-15T
• Device Lot Number: 60104G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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
• Treatment: CONCOMITANT MEDICAL DEVICES