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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER

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AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012272-15
Device Problems Difficult To Position (1467); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/06/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Concomitant products: guide wire: runthrough. Guiding catheter: cordis 6fr jr 3. 5 sh. 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 procedure was to treat a lesion in the mid left anterior descending artery with mild tortuosity and moderate calcification. A 2. 5x15 mm rx trek balloon dilatation catheter (bdc) was unable to advance through a 6 fr non-abbott guide catheter. The non-abbott guide wire was damaged and the trek bdc was stuck inside of the guide catheter. A new non-abbott guide wire and a new 2. 5x15 mm rx trek bdc were able to be advanced through the same non-abbott guide catheter. Angioplasty was successfully performed. There was no adverse patient effect and no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual, dimensional and functional inspections were performed on the returned device. The reported difficulty to remove and difficulty to position issues could not be confirmed. The investigation was unable to determine a conclusive cause for the reported difficulties. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot. 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.
 
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Brand NameTREK 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 Key5988764
MDR Text Key56335449
Report Number2024168-2016-06538
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K103110
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,Followup
Report Date 11/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2019
Device Catalogue Number1012272-15
Device Lot Number60604G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/09/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
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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