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

Catalog Number 1012455-08

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: guide wire: versaturn, stent: endeavor 3.0x15mm, 3.5x24mm.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat two target lesions.The first lesion located in the mid-left circumflex coronary artery was treated with a 3.0 x 15 mm non-abbott stent.During treatment of the second target lesion located in the proximal left anterior descending coronary artery, after deployment of a 3.5 x 24 mm non-abbott stent, the 5.0 x 8 mm nc trek balloon dilatation catheter was advanced and inflated once at 14 atmospheres for 10 seconds.The balloon would not fully deflate and was observed to have a poor re-fold of the balloon which resulted in resistance during retraction between the balloon catheter and the non-abbott stent; however, the balloon catheter was ultimately retrieved successfully.Although a delay in the procedure was reported, there were 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 deflation issue was confirmed.The folded/winged balloon could not be confirmed due to the condition of the returned device.The difficulty to remove could not be replicated in a testing environment as they are based on operational circumstances.The investigation determined the reported complaints appear 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 TREK CORONARY 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: 5951239
• MDR Text Key: 55031323
• Report Number: 2024168-2016-06083
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 10/04/2016

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: 10/31/2018
• Device Catalogue Number: 1012455-08
• Device Lot Number: 51102G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2016
• Initial Date FDA Received: 09/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• 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