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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER

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ABBOTT VASCULAR TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012272-30
Device Problem Off-Label Use (1494)
Patient Problem Perforation of Vessels (2135)
Event Date 07/07/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device location was not provided and it is unknown if the device is returning for analysis. A follow-up report will be submitted with all additional relevant information. The udi is unknown as the part/lot numbers were not provided.
 
Event Description
It was reported that on (b)(6) 2021, the patient presented for a percutaneous peripheral intervention. A non-abbott stent was implanted in the distal superficial femoral artery, reducing stenosis. Angioplasty was then performed on the left anterior tibial (at) artery using a 2. 5x30mm trek balloon catheter. The at stenosis was reduced from 80% to 30% with good results, however a mid-left at perforation was observed. Balloon angioplasty was performed; however, it was not successful at sealing the perforation. A 2. 8x26mm graftmaster stent was then implanted mid-distal at, without a device issue reported, sealing the perforation. Reportedly, hemostasis was achieved. No additional information was provided regarding this issue.
 
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Brand NameTREK CORONARY DILATATION CATHETER
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR COSTA RICA, REG # 3009564766
52 calle 3 b31 coyol free zone
el coyol alajuela
CS
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key12212028
MDR Text Key262955792
Report Number2024168-2021-06357
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
Type of Report Initial,Followup
Report Date 09/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1012272-30
Device Lot Number10112G1
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 Received08/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/12/2021
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: 07/22/2021 Patient Sequence Number: 1
Treatment
6 FRENCH MB1 GUIDE CATHETER; ZILVER STENT
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