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

Catalog Number 1012451-12

Device Problems Improper or Incorrect Procedure or Method (2017); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/23/2016

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 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 lesion in the left anterior descending artery.A 3.5x12mm nc trek rx balloon dilatation catheter (bdc) was removed from the dispenser coil and no resistance was noted.The nc trek was advanced toward the target lesion and the balloon markers could not be seen under fluoroscope.The device was removed and it was noted that the balloon was missing from the shaft.Reportedly the patient anatomy was scanned and it was determined that the balloon was never on the catheter after the scan.The site could not confirm that the balloon was present prior to advancing the balloon into the patient anatomy.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: (b)(4).Visual inspection was performed on the returned device.The reported missing balloon was confirmed as outer member and inner member separations were noted.A review of the lot history record identified no manufacturing nonconformities.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.It should be noted coronary dilatation catheters, nc trek rx, global, instructions for use states: prior to use examine all equipment carefully for defects.Examine the dilatation catheter for bends, kinks, or other damage.Do not use any defective equipment.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.The investigation was unable to determine a conclusive cause for the reported difficulty.

Event Description

It was reported that the procedure was to treat a lesion in the left anterior descending artery.A 3.5x12mm nc trek rx balloon dilatation catheter (bdc) was removed from the dispenser coil and no resistance was noted.Reportedly the nc trek balloon was soaked prior to use and air aspiration was performed outside the anatomy prior to use.The nc trek was advanced toward the target lesion and the balloon markers could not be seen under fluoroscope.The device was removed and it was noted that the balloon was missing from the shaft.Reportedly the patient anatomy was scanned and it was determined that the balloon was never on the catheter after the scan.The site could not confirm that the balloon was present prior to advancing the balloon into the patient anatomy.However, the physician felt that the balloon was missing from the catheter prior to advancing the device into the anatomy.There was no adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.

• 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: 5701663
• MDR Text Key: 46811608
• Report Number: 2024168-2016-03647
• 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: 06/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 1012451-12
• Device Lot Number: 31213GA
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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