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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT MINI TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012270-15
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intimal Dissection (1333)
Event Date 01/23/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). Medical devices: dilatation catheter: sprinter 1. 25x12, ryujin 2. 0x15, guide wire: runthrough ns, miracle 3 , bivalirudin. The device was not returned for evaluation. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this event. The reported patient effect of intimal dissection is listed in the coronary dilatation catheters (cdc), mini trek, rx, global, instructions for use as a known patient effect. A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined and there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
 
Event Description
It was reported that on (b)(6) 2017, a 2. 0x15 mm mini trek was used to dilate the chronic total occlusion in the distal right coronary artery (rca). After balloon dilatation, a dissection was noted in the distal rca. A stent was implanted to treat the dissection, resolving the event. There was no additional information provided.
 
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Brand NameMINI 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)
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 Key7115444
MDR Text Key94788477
Report Number2024168-2017-09710
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 12/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2019
Device Catalogue Number1012270-15
Device Lot Number60514G2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/13/2017 Patient Sequence Number: 1
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