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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012453-12
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 12/18/2018
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 to treat a moderately calcified lesion in the mildly tortuous proximal left anterior descending coronary artery. A 4. 0x12 mm nc trek balloon dilatation catheter (bdc) was advanced without resistance for post-dilatation of an unspecified stent. After post-dilatation the bdc was being pulled back and became stuck with the guide catheter. The bdc was re-inflated and deflated again to attempt removal and the physician had to pull firmly to successfully remove the bdc. Upon inspection after removal, the distal end of the balloon looked thick and the balloon material did not look refolded properly. A new, same size nc trek was used to complete the procedure. There were no adverse patient effects and there was no reported clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). A visual inspection was performed on the returned device. The reported winged/wrinkled balloon was confirmed. The reported difficulty to remove from a 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 coronary dilatation catheter, 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. The investigation determined the reported/noted difficulties of difficult to remove, winged/wrinkled balloon, kinks and bends on the device appear to be related to circumstances of the procedure. In this case, based on the returned analysis 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 unusual appearance and/or the winged/wrinkled distal end of the balloon. There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
 
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Brand NameNC TREK CORONARY DILATATION CATHETER
Type of DeviceCORONARY 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 Key8227835
MDR Text Key132504539
Report Number2024168-2019-00197
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
Device Catalogue Number1012453-12
Device Lot Number80110G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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