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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR GUIDE WIRE ACC.KIT W/COPILOT®; ACCESSORIES

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ABBOTT VASCULAR GUIDE WIRE ACC.KIT W/COPILOT®; ACCESSORIES Back to Search Results
Model Number 1003330
Device Problems Leak/Splash (1354); Unstable (1667)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/03/2023
Event Type  malfunction  
Event Description
It was reported that the procedure was to treat the left anterior descending (lad) coronary artery with 80% stenosis.The clamp seal of the copilot would not tighten and leaked.There was no patient involvement and there was no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
 
Manufacturer Narrative
The device was returned for analysis.The reported unstable [clamp seal] and the reported leak / splash were unable to be confirmed.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 incidents from this lot.As the reported difficulties were unable to be confirmed during return analysis, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the cap/clamp seal was not fully tightened/closed; thus resulting in the reported unstable [clamp seal] and the reported leak / splash.There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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Brand Name
GUIDE WIRE ACC.KIT W/COPILOT®
Type of Device
ACCESSORIES
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 2024168
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key16629631
MDR Text Key312326319
Report Number2024168-2023-03109
Device Sequence Number1
Product Code DTL
UDI-Device Identifier08717648013980
UDI-Public08717648013980
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K991102
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1003330
Device Catalogue Number1003330
Device Lot Number60405067
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/03/2023
Initial Date FDA Received03/28/2023
Supplement Dates Manufacturer Received05/15/2023
Supplement Dates FDA Received06/05/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/19/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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