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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. RIVAL PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER

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BARD PERIPHERAL VASCULAR, INC. RIVAL PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number RV135415
Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problem Injury (2348)
Event Date 06/12/2020
Event Type  Injury  
Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable. Expiry date (11/2022), (b)(4).

 
Event Description

It was reported that during an angioplasty procedure, the pta balloon tip allegedly ruptured and detached. It was further reported that a cut down procedure was required to remove the detached material. There were no further reported complications to the patient.

 
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Brand NameRIVAL PTA DILATATION CATHETER
Type of DevicePTA BALLOON DILATATION 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 NY 12804
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key10262648
MDR Text Key198474675
Report Number2020394-2020-04388
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK120722
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 07/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/13/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberRV135415
Device Catalogue NumberRV135415
Device LOT NumberGFDY0822
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 07/13/2020 Patient Sequence Number: 1
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