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

Catalog Number 1012449-15T

Device Problem Leak/Splash (1354)

Patient Problems Air Embolism (1697); Bradycardia (1751)

Event Date 10/20/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4). Concomitant medical products: guide wire: run through ns, guide cath: heartrail jr3. 5. The nc 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. The device was received. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a 90% restenosis with moderate calcification in the mid right coronary artery. The lesion was pre-dilated with a cutting balloon and a 3. 0x15mm nc tenku balloon dilatation catheter (bdc) was advanced to the lesion; however, when attempting to inflate the balloon to 18 atmospheres the balloon inflated slightly at first, then pressure loss occurred inside the anatomy and bradycardia occurred. Contrast escaping from the balloon was not confirmed under fluoro. The device was removed from the patient and an attempt to inflate the balloon was made; however, it would not inflate. The 3. 0x15mm nc tenku bdc had been prepped outside the anatomy prior to use and there was no issue or leak noted. The bradycardia resolved on its own and the procedure was successfully completed with a new 3. 0x15mm nc tenku bdc and a 3. 0mm drug catheter balloon. The physician suspected air was introduced into the vessel due to a hole in the shaft which caused the bradycardia. There was no clinically significant delay in the procedure. No additionally information was provided.

Manufacturer Narrative

(b)(4). Evaluation summary: visual, functional and scanning electron microscopy analysis were performed on the returned device. The reported leak was confirmed. The investigation determined the reported leak and subsequent patient effect appears to be related to circumstances of the procedure. 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. 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: 6096048
• MDR Text Key: 59737103
• Report Number: 2024168-2016-07891
• 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

• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 1012449-15T
• Device Lot Number: 60202G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/04/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/11/2016 Patient Sequence Number: 1