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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number U4150230
Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919); Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2017
Event Type  malfunction  
Manufacturer Narrative
Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. Conclusion: the device was returned for evaluation in two segments; one guidewire was also returned stuck in one of the segments. A visual inspection found a complete balloon detachment at the proximal balloon joint. Additionally, the inner guidewire lumen was found to be completely detached, and one of the marker bands was detached and not returned. Therefore, the investigation is confirmed for balloon, catheter, and marker band detachments. The investigation is also confirmed for the reported guidewire issue, as the guidewire could not be removed from the device, and as bunching and stretching were noted throughout the device. The investigation is also confirmed for a dislodged marker band on the guidewire lumen. Stretching was noted at the inner lumen break, likely indicating that force was applied to the returned device. It is likely that the force applied to the device resulted in the identified detachments and bunching. However, the definitive root cause for the reported guidewire issue could not be determined based upon the available information. Labeling review: the current ifu (instructions for use) states: precautions: do not remove the guidewire in situ to shoot contrast through the wire lumen or perform a wire exchange. If the wire is removed while the balloon catheter is situated in tortuous anatomy, the risk of kinking the catheter is increased. If resistance is felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter and guidewire/introducer sheath as a single unit. Dilatation catheter preparation: prepare the wire lumen of the catheter by attaching a syringe to the wire lumen hub and flushing with sterile saline solution. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that during an angioplasty procedure in the sfa, the pta balloon allegedly became stuck on the guidewire after the first inflation. Reportedly, the balloon catheter and guidewire were removed as one unit and a new catheter was used to complete the procedure. There was no reported patient injury.
 
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Brand NameULTRAVERSE 014 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)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford
EI
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key7249960
MDR Text Key99321469
Report Number2020394-2018-00069
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121856
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 02/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Model NumberU4150230
Device Catalogue NumberU4150230
Device Lot NumberCMBR0410
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/11/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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