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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 1012448-08
Device Problem Detachment Of Device Component (1104)
Patient Problem No Patient Involvement (2645)
Event Date 05/28/2018
Event Type  malfunction  
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 additional relevant information.
 
Event Description
It was reported that the shaft of a 2. 75 x 8mm nc trek balloon dilatation catheter broke when it went through the rotating hemostatic valve during preparation. There was no patient involvement. Another device was used to successfully complete the procedure. Another nc trek was used to successfully complete the procedure. There was no clinically significant delay in the procedure and no adverse patient effects. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual inspection was performed on the returned device. The reported separation was confirmed. 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 determined the reported difficulty appears 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.
 
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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
MDR Report Key7611824
MDR Text Key111852088
Report Number2024168-2018-04575
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Catalogue Number1012448-08
Device Lot Number70517G2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/24/2018
Is This a Reprocessed and Reused Single-Use Device? No

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