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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA CATHETER PTA BALLOON DILATATION CATHETER

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number U357588
Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problem Embolism (1829)
Event Date 07/27/2020
Event Type  Injury  
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed. The return of the sample is pending. The investigation of the reported event is currently underway. (expiry date: 01/2023).
 
Event Description
It was reported that performed a post-dilatation procedure, the pta balloon allegedly ruptured. The hcp withdrew the device with difficulty, elongation of the shaft and missed distal part of the pta they noticed a circumferential rupture that make the way out very difficult, part of the balloon while performing a thrombo-embolectomy. This part could have migrated lower in the leg, causing embolism and ischemia. The patient was hospitalized.
 
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Brand NameULTRAVERSE 035 PTA CATHETER
Type of DevicePTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford N A
EI N A
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key10412789
MDR Text Key203091834
Report Number2020394-2020-05391
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K142261
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberU357588
Device Catalogue NumberU357588
Device Lot NumberCMEP0527
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2020
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: 08/17/2020 Patient Sequence Number: 1
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