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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 1012453-15
Device Problems Failure to Fold (1255); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/16/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Evaluation summary: a visual inspection was performed on the retuned device and the reported balloon rewrap/folded issue was confirmed. The reported difficulty to remove the device from a guiding catheter could not be confirmed due to the returned 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. The investigation was unable to determine a conclusive cause for the reported balloon refold/rewrap issue. Although a conclusive cause for the reported balloon fold issue could not be identified, the reported difficulty to remove through the introducer sheath appears to be related to circumstances of the procedure as the winged/flat balloon did not properly fit through the distal end of the guiding catheter during retraction causing resistance. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that the procedure was performed to treat a lesion in the left main coronary artery with no tortuosity and mild calcification. Following deployment of an unspecified stent, a 4. 00 x 15 mm nc trek rx balloon dilatation catheter was advanced for successful post stent dilatation. Despite fully deflating, the balloon of the bdc failed to rewrap tightly and met resistance with the unspecified guide catheter on removal from the anatomy. Further inflation and deflation of the balloon was attempted; however, the rewrap problems remained and the bdc and guide catheter had to be removed as a single unit. A new guide catheter was placed to successfully continue the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
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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 Key8015348
MDR Text Key125435468
Report Number2024168-2018-08235
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
Report Date 10/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Catalogue Number1012453-15
Device Lot Number80419G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2018
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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