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

Catalog Number 1012454-08

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 08/22/2014

Event Type  malfunction  

Event Description

It was reported that the procedure was treating a moderately calcified lesion in the proximal right coronary artery.During post-dilatation, the 4.5x8mm nc trek balloon dilatation catheter (bdc) was inflated to 22 atmospheres.The balloon was deflated; however, was noted to have a bad re-fold and experienced resistance retracting into the 6f guiding catheter.The balloon was inflated again slightly and then deflated in an attempt to obtain a better re-fold, but the balloon still had a bad re-fold.The balloon was able to be retracted about 80% into the guiding catheter.Due to the resistance with the guiding catheter during retraction, the guiding catheter, balloon, and guide wire were all removed together as a single unit.Post-dilatation was confirmed to be successful and nothing further needed to be done.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4): above rated burst pressure (rbp).Evaluation summary: the device was returned for evaluation.The reported difficulty and poor refold was not confirmed; however it may have been due to the circumstances of the procedure.Based on visual, dimensional and functional analysis of the returned device, there is no indication of a product deficiency.A review of the lot history record revealed no non-conformances that would have contributed to this complaint.A query of the electronic complaint handling database revealed no other incidents for difficult to remove from the guiding catheter, improper method, or poor refold reported from this lot.Based on the information reviewed, there is no indication of a product deficiency.It should be noted that the instructions for use (ifu) states that the balloon pressure should not exceed the rbp.It is unknown if the reported ifu deviation directly caused or contributed to the reported complaint.

• 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 462
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 4093825
• MDR Text Key: 16782035
• Report Number: 2024168-2014-05962
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/22/2014

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: 11/30/2015
• Device Catalogue Number: 1012454-08
• Device Lot Number: 31212G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2014
• Initial Date FDA Received: 09/16/2014
• 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