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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 U357584
Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907)
Patient Problem Injury (2348)
Event Date 06/13/2019
Event Type  Injury  
Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation of the reported event is currently underway.(expiry date: 01/2022).
 
Event Description
It was reported that during an angioplasty procedure in the left upper arm fistula, the tip of the pta balloon allegedly detached after the first inflation attempt.It was further reported that medical intervention was required to remove the detached segment.Reportedly, another balloon was used to complete the angioplasty procedure.The patient was reported stable post procedure.
 
Event Description
It was reported that during an angioplasty procedure in the left upper arm fistula, the tip of the pta balloon allegedly detached after the first inflation attempt.It was further reported that medical intervention was required to remove the detached segment.Reportedly, another balloon was used to complete the angioplasty procedure.The patient was reported stable post procedure.
 
Manufacturer Narrative
Manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was not required.Investigation summary: the device was returned for evaluation.A visual inspection was performed and a compound rupture was noted to the balloon, with only the proximal portion of the balloon attached to the device.The inner lumen was noted to be stretched away form the end of the outer lumen.Bunching was noted to the inner lumen near the end of the outer lumen.The distal portion of the inner lumen and the remaining portion of the balloon were detached from the device, and not available for evaluation.Only one marker band was noted to the remaining device.No other anomalies were noted to the device.Therefore, the investigation is confirmed for the compound balloon ruptured, as the balloon was noted to have a compound rupture.The investigation is confirmed for the catheter shaft and balloon detachment, as the distal portion of the inner lumen and the remaining portion of the balloon were detached from the device.The definitive root cause for the identified balloon compound rupture, balloon detachment and catheter shaft detachment could not be determined based upon available information.It is unknown whether patient or procedural issues contributed to the event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
 
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Brand Name
ULTRAVERSE 035 PTA CATHETER
Type of Device
PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key8750868
MDR Text Key149761115
Report Number2020394-2019-01343
Device Sequence Number1
Product Code LIT
UDI-Device Identifier00801741093951
UDI-Public(01)00801741093951
Combination Product (y/n)N
PMA/PMN Number
K142261
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberU357584
Device Catalogue NumberU357584
Device Lot NumberCMDP0261
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2019
Date Manufacturer Received11/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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