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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR 20/30 PRIORITY PACK ACCESSORY KIT; ACCESSORIES

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ABBOTT VASCULAR 20/30 PRIORITY PACK ACCESSORY KIT; ACCESSORIES Back to Search Results
Model Number 1000186-115
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2020
Event Type  malfunction  
Manufacturer Narrative
Estimated dates.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.
 
Event Description
It was reported that during use there was leaking from the rotating hemostatic valve (rhv), causing loss of pressure tracing with other devices.A non-abbott rhv was used to complete the procedure.There were no adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
B3: estimated date.The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.It is possible the device was not fully connected/tightened; however as the device was not returned for analysis this cannot be confirmed.The investigation determined a conclusive cause for the reported leak cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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Brand Name
20/30 PRIORITY PACK ACCESSORY KIT
Type of Device
ACCESSORIES
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key11049745
MDR Text Key241254040
Report Number2024168-2020-10786
Device Sequence Number1
Product Code MAV
UDI-Device Identifier08717648015274
UDI-Public08717648015274
Combination Product (y/n)N
PMA/PMN Number
K961471
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/18/2021
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 Number1000186-115
Device Catalogue Number1000186-115
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/01/2020
Initial Date FDA Received12/21/2020
Supplement Dates Manufacturer Received01/06/2021
Supplement Dates FDA Received01/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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