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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 1012453-20
Device Problems Break (1069); Difficult To Position (1467)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/23/2016
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: (b)(4). Visual inspection was performed on the returned device. An inner member separation was observed. The reported difficulty to position could not be replicated in a testing environment due to the condition of the returned device. 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. Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device. The investigation was unable to determine a conclusive cause for the reported difficulty. The noted inner member separation appears to be related to circumstances of the procedure.
 
Event Description
It was reported that the 4. 0x20 mm nc trek rx balloon dilatation catheter (bdc) could not be advanced over the guide wire. There were no adverse patient effects and clinically significant delay during the procedure. A same size nc trek bdc was used to complete the procedure. No additional information was provided. Returned device analysis revealed an inner member separation.
 
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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)
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
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 Key5795822
MDR Text Key49633118
Report Number2024168-2016-04592
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 07/14/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2018
Device Catalogue Number1012453-20
Device Lot Number5052961
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2015
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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