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

Catalog Number 1012272-12

Device Problems Difficult To Position (1467); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Device: above rated burst pressure, failure to follow steps/instructions, incorrect prep.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

It was reported that the procedure was to treat a lesion in the mid left anterior descending coronary artery.A 2.5x12mm trek rx balloon dilatation catheter (bdc) was prepped prior to use with saline; however, it was not soaked prior to use.The bdc was advanced to the lesion and an attempt to inflate the balloon was made; however, there was no visibility of the balloon inflating on angiography due to the use of saline instead of contrast.Pressure of more than 29 atmospheres was applied and then the balloon ruptured.The procedure was successfully completed with another unknown balloon dilatation catheter.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).Correction: it was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.The device was not returned for analysis.It was reported that the balloon dilatation catheter (bdc) was inflated to a pressure of more than 29 atmospheres (atm).It should be noted that the warnings section of the trek rx coronary dilatation catheter (cdc), instructions for use (ifu) specifies: balloon pressure should not exceed the rated burst pressure (rbp).The label for the 2.50x12mm trek rx cdc specifies a rbp of 14 atm.In addition, it was reported that the device was prepped prior to use with saline.It should be noted that the preparation for use section of the ifu specifies: prepare an inflation device with the recommended contrast medium according to the manufacturers instructions.It was also reported that the balloon was not soaked prior to use.It should be noted that the ifu specifies: submerge the balloon in sterile heparinized normal saline during balloon preparation to activate the coating.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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to the use errors.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: 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: 6197221
• MDR Text Key: 63328352
• Report Number: 2024168-2016-09138
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103110
• 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: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 1012272-12
• Device Lot Number: 60905G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• 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: 83 YR
• Patient Weight: 71