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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 1012407-30
Device Problems Difficult To Position (1467); Difficult to Remove (1528)
Patient Problem No Patient Involvement (2645)
Event Date 01/26/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4). The device was returned for analysis. The difficult to position and remove the guide wire were unable to be confirmed. Based on visual, dimensional and functional analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design or labeling. The investigation was unable to determine a conclusive cause for the reported difficulties. A review of the lot history record revealed no non-conformances. Additionally, a review of the complaint history identified no other incidents reported from this lot. Based on the information reviewed, there is no indication of a product quality issue with the respect to manufacturing, design, or labeling.
 
Event Description
It was reported that the procedure was to treat a lesion in the right coronary artery with heavy calcification and moderate tortuosity. A 3x30mm trek over the wire (otw) balloon dilatation catheter (bdc) was prepped/flushed prior to use. A non-abbott. 014 guide wire was advanced into the backend of the trek bdc. Resistance was noted and the guide wire was not able to pass through the catheter tip. The guide wire could not be removed. Thus, the device was not used and there was no patient involvement. Multiple non-abbott balloons were able to traverse over the same guide wire. A 3. 5x38mm xience alpine stent delivery system (sds) was advanced toward the target lesion and failed to cross due to the patient anatomy. There were no other device issues noted. The device was removed and replaced with a non-abbott stent to complete the procedure. There was no adverse patient effect and no clinically significant delay in the procedure. No additional information was provided.
 
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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 Key5447488
MDR Text Key38854383
Report Number2024168-2016-00996
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 02/19/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2018
Device Catalogue Number1012407-30
Device Lot Number50228G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2015
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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