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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SIDEKICK SUPPORT CATHETER

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BARD PERIPHERAL VASCULAR, INC. SIDEKICK SUPPORT CATHETER Back to Search Results
Catalog Number SD70AJ
Device Problems Material Separation (1562); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/23/2021
Event Type  Malfunction  
Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed. The device has been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. (expiry date: 05/2023).

 
Event Description

It was reported that during a recanalization procedure, fibrous things which looked like strings allegedly came out of the device. There was no reported patient injury.

 
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Brand NameSIDEKICK
Type of DeviceSUPPORT CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury 12804
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key12194469
MDR Text Key262394985
Report Number2020394-2021-01349
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK131493
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/02/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/20/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberSD70AJ
Device LOT NumberGFES1565
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/08/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2021
Was Device Evaluated By Manufacturer? Yes
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: 07/20/2021 Patient Sequence Number: 1
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