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

Catalog Number 1012452-20

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2016

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) - against resistance.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

The procedure was to treat a de novo lesion located in the mildly calcified, mildly tortuous, mid circumflex artery.During advancement of the 3.75 x 20 mm nc trek balloon catheter in the guiding catheter resistance was felt.More force was used which resulted in kinking of the shaft.Upon retraction of the balloon the mid shaft separated; however, the separation was outside the patient and removed without issue.A new balloon catheter was used to complete the case successfully.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.The reported separation was confirmed.The kink and the difficulty to position were not confirmed.It was reported that the device was pushed against the reported resistance, kinking the shaft and upon further manipulation the shaft ultimately separated.It should be noted that the nc trek rx instructions for use states: if resistance is felt, determine the cause before proceeding.Continuing to advance or retract the catheter while under resistance may result in damage to the vessels and / or damage / separation of the catheter.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.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 difficult to position with the guiding catheter; however, the kink and shaft separation appear to be related to the use error.

• 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: 5805585
• MDR Text Key: 49954228
• Report Number: 2024168-2016-04727
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: LE
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2016

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: 1012452-20
• Device Lot Number: 51110G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2016
• Initial Date FDA Received: 07/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/23/2016
• 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