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

Catalog Number 1012455-20

Device Problems Detachment Of Device Component (1104); Deflation Problem (1149); Difficult to Remove (1528); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide catheter: 7f, sheath: 11f, stent: xience alpine(2.5 x 38mm, 3.0x38mm, 4.0x38mm).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 the procedure was performed to treat a chronic total occlusion (cto) lesion in the right coronary artery (rca).Three xience stents (from distal to proximal: 2.5 x 38mm, 3.0x38mm, 4.0x38mm xience alpine) were implanted without issue.The 5.0 x 20 mm nc trek balloon dilatation catheter (bdc) was advanced for standard post-dilatation.Three inflations were made from the distal to the proximal rca, at 12-14 atmospheres (atm), for 15 seconds.After the last deflation, the balloon was retracted, but slight resistance was noted with the proximal xience stent, and then with the guiding catheter.The guiding catheter was disengaged from the rca and the catheter and balloon were pulled into the aorta.It was noted that the balloon was bunching at the end of the guiding catheter, and could not be retracted.It was believed that the balloon was not rewrapping properly; therefore, it was inflated to 10 atm to correct the rewrapping issue, but the balloon did not deflate.A guide wire was advanced in an attempt to rupture the balloon, but this was not successful.The nc trek shaft was then cut outside the anatomy and an 11 (b)(6) sheath was inserted into the femoral artery in an attempt to retrieve the device, but the nc trek shaft broke 4-5 inches outside the anatomy.The physician pulled the separated portion out of the femoral artery by hand, and removed the device.Angiography was performed, and confirmed there was no injury to the femoral artery.The patient was confirmed to be stable and the procedure was complete.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned for analysis.Visual inspection was performed on the returned device.The reported separation and balloon bunching were confirmed.The reported difficulty removing the device from the stent and guiding catheter could not be replicated in a testing environment as it is based on operational circumstances.The reported deflation issue could not be replicated in a testing environment due to the condition of the returned device.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 separation, balloon bunching and difficulty removing the device from the stent and guiding catheter 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: 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: 7183613
• MDR Text Key: 97052762
• Report Number: 2024168-2018-00298
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 1012455-20
• Device Lot Number: 70821G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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
• Patient Outcome(s): Required Intervention