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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); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2022
Event Type  malfunction  
Event Description
It was reported that during preparation of 2 copilots the valves were reported to have leaks in the proximal hub.The leaks were noted during injection of the contrast.There was no patient involvement and no clinically significant delay reported in the procedure.No additional information was provided.
 
Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The other copilot device referenced is filed under a separate medwatch report number.
 
Event Description
Subsequent to the initial medwatch report, it was reported that there was only one copilot that was used in the procedure.This device was reported in error.No second device used.No event to be reported.No additional information was provided.
 
Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A similar incident query was not performed as there was no reported device issues for the complaint.Not applicable as this complaint was wrongly reported by the hospital as there was only one device that presented an issue (reference: cn-128075).There is no indication of a product quality issue with respect to manufacture, design or labeling.B5: description of event d9, h3: there was only one device used in the procedure.This device was not used in the procedure.Reported in error.No device to be returned for evaluation.H6: medical device problem code 1354 - removed.
 
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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 Key15375320
MDR Text Key304559377
Report Number2024168-2022-09488
Device Sequence Number1
Product Code DTL
UDI-Device Identifier08717648013980
UDI-Public08717648013980
Combination Product (y/n)N
Reporter Country CodeCS
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 10/26/2022
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 Expiration Date04/30/2024
Device Model Number1003330
Device Catalogue Number1003330
Device Lot Number60365810
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/19/2022
Initial Date FDA Received09/07/2022
Supplement Dates Manufacturer Received10/24/2022
Supplement Dates FDA Received10/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/03/2022
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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