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

Catalog Number 1012453-08

Device Problems Failure to Fold (1255); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2018

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 relevant information.

Event Description

It was reported that the procedure was performed to treat a coronary lesion.A 4.00 x 8 mm nc trek rx balloon dilatation catheter (bdc) was advanced to the lesion for post-dilatation.The contrast mix was 50 ml of contrast diluted with 18 ml of saline.The balloon of the bdc was inflated twice to 18 atmospheres.There were no problems with deflation of the balloon; however the balloon did not refold correctly and the bdc met resistance with the guide catheter on removal.The bdc was removed independently with some force.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: a visual inspection was performed, and the reported winged/wrinkled balloon was confirmed.The reported difficulty to remove the device from the guiding catheter could not be confirmed due to the condition of the balloon.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents reported from this lot.It should be noted that nc trek rx, instructions for use states to use: 60% contrast medium diluted 1:1 with normal saline.In this case, the use of a 50:18 contrast solution mix does not appear to have contributed to the reported complaint.The investigation determined the reported/noted difficulties of difficult to remove, winged/wrinkled balloon and stretched inner/outer member appear to be related to circumstances of the procedure.It is likely that the balloon was not fully deflated during retraction causing resistance with the distal end of the guiding catheter resulting in the winged/wrinkled balloon and stretched materials at the mid-lap seal.There is no indication of a product quality issue with respect to 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
• MDR Report Key: 8218352
• MDR Text Key: 132205712
• Report Number: 2024168-2019-00068
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K110134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 1012453-08
• Device Lot Number: 81006G1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/04/2019
• Date Manufacturer Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1