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

Catalog Number 1012454-15

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Folded (2630)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).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.

Event Description

It was reported the procedure was to treat a lesion with no tortuosity and mild calcification in the mid right coronary artery (rca).The 4.5 x 15 mm nc trek balloon catheter was advanced to the target lesion without resistance noted.The nc trek balloon was inflated to 20 atmospheres two times and there were no issues noted during deflation.However, when the nc trek was to be withdrawn, the balloon could not be retrieved back into the 6fr guiding catheter.The devices had to be withdrawn together as one unit.Outside the patient anatomy, it was noted that the balloon was still partially inflated causing the resistance with the guiding catheter.The patient outcome was good.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.The reported difficulty to remove was confirmed.The partially inflated balloon could not be replicated in a testing environment as it was based on operational circumstances.It should be noted the instruction for use, states: balloon pressure should not exceed the rated burst pressure (rbp).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 similar incidents from this lot.The investigation determined the reported difficulty removing the device from the guiding catheter appears to be related to circumstances of the procedure; however, a conclusive cause for the reported partially inflated balloon could not be determined.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: 6190798
• MDR Text Key: 63201677
• Report Number: 2024168-2016-09048
• 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: 02/16/2017

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: 07/31/2019
• Device Catalogue Number: 1012454-15
• Device Lot Number: 60824G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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
• Patient Age: 40 YR
• Patient Weight: 105