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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
Model Number 1012274-15
Device Problems Off-Label Use (1494); Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Patient Problem Embolism/Embolus (4438)
Event Date 08/16/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). The device was not returned for evaluation. 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 similar incidents and/or complaints from this lot. Additionally, it was reported by the account that the balloon separated in the anatomy, causing an embolism, and a snare device was used to retrieve the separated portion. The reported patient effect of embolism is listed in the coronary dilatation catheters (cdc), trek rx and mini trek rx, global, instructions for use as a known patient effect. The investigation was unable to determine a conclusive cause for the reported separation, difficulty advancing and removing the device; however, the reported removal of foreign body and additional treatment appear to be related to circumstances of the procedure. A conclusive cause for the reported embolism and the relationship to the device, if any, cannot be determined. There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that the procedure was performed to treat an unspecified artery in the leg. A 3x15mm trek balloon dilatation catheter (bdc) felt unspecified resistance during advancement and withdrawal. The balloon separated in the anatomy, causing an embolism, which was retrieved with a snare device. The patient is doing well. There were no reported adverse patient sequelae and no reported 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)
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 Key12468221
MDR Text Key271289239
Report Number2024168-2021-08139
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1012274-15
Device Catalogue Number1012274-15
Device Lot Number10420G2
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 Received08/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/20/2021
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: 09/14/2021 Patient Sequence Number: 1
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