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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 1012448-15
Device Problems Inflation Problem (1310); Difficult To Position (1467); Difficult to Remove (1528); Physical Property Issue (3008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/24/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Visual and functional inspections were performed on the returned device. The reported physical property issue (damage), inflation issue and difficulty positioning the device with the guiding catheter could not be confirmed. The reported difficulty removing the protective sheath could not be replicated in a testing environment since the sheath was not returned. 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 other incidents from this lot. The investigation was unable to determine a conclusive cause for the reported difficulty removing the protective sheath or lumen damage; however, the reported difficulty positioning the device with the guiding catheter and inflation issue appear to be related to operational context. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
Manufacturer Narrative
(b)(4) during processing of this complaint, attempts were made to obtain complete event, patient and device information. The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that the procedure was to treat a lesion in the left anterior descending artery. There was difficulty removing the yellow protective sheath off a 2. 75x15mm nc trek balloon dilatation catheter (bdc). The sheath was able to be removed; however, there was difficulty advancing the bdc through the guiding catheter. The bdc was removed and it was noticed that the lumen was damaged. After removal an attempt to inflate the balloon was made, but the balloon would not inflate. The procedure was successfully completed with another nc trek balloon catheter. There was no clinically significant delay in the procedure and no adverse patient effects. 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 Key6645329
MDR Text Key192365356
Report Number2024168-2017-05118
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2019
Device Catalogue Number1012448-15
Device Lot Number61226G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2016
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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