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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR MINI TREK CORONARY DILATATION CATHETER

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ABBOTT VASCULAR MINI TREK CORONARY DILATATION CATHETER Back to Search Results
Model Number 1012270-12
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/11/2021
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that during device preparation of the 2x12mm mini trek coronary dilatation catheter, air bubbles were observed in the syringe during aspiration.No other device damage was noted.The device was not used in the procedure.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
Visual, functional and scanning electron microscopy (sem) inspections/analysis were performed on the returned device.The reported leak was confirmed.Additionally, the inner member was observed torn proximal to the balloon proximal seal.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.The investigation determined a potential product quality issue based on the reported leak and noted inner member tear proximal to the proximal balloon seal.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
 
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Brand Name
MINI TREK CORONARY DILATATION CATHETER
Type of Device
CORONARY DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key11270407
MDR Text Key230927001
Report Number2024168-2021-00822
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648138140
UDI-Public08717648138140
Combination Product (y/n)N
PMA/PMN Number
K103110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 06/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2023
Device Model Number1012270-12
Device Catalogue Number1012270-12
Device Lot Number00706G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2021
Date Manufacturer Received06/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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