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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 1012452-08
Device Problems Detachment Of Device Component (1104); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 06/14/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information. 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 during device unpacking and prior to use, the 3. 75 x 8 mm nc trek plastic holder was noted to be kinked. While attempting to remove the device from the holder, the hub detached from the catheter shaft. There was no damage noted to the outer chipboard box. There was no patient involvement. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Visual inspection was performed on the returned device. The reported kinked hoop/coil and the separation were 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 kinked hoop/coil and the separation appear to be related to a potential product quality issue. Continued assessment of this issue per site operating procedures is being performed. These devices will continue to be monitored.
 
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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 Key7643664
MDR Text Key112714994
Report Number2024168-2018-05092
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,health
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
Device Catalogue Number1012452-08
Device Lot Number80131G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/15/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/02/2018
Is This a Reprocessed and Reused Single-Use Device? No

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