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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number U41502H22
Device Problems Break (1069); Difficult to Open or Remove Packaging Material (2922)
Patient Problem No Patient Involvement (2645)
Event Date 07/20/2017
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. This is the only complaint reported to date for this lot number and failure mode. Conclusion:the device was returned. A visual inspection found a complete break in the outer catheter, as well as stretching of the inner guidewire lumen. Additionally, the balloon guard was found to be bunched. Based on the observed damage to the device and balloon guard, the investigation is confirmed for the reported difficultly removing the device from the balloon stylet and guard. Based on the condition of the returned sample, the difficulty experienced during removal led to excessive force being applied, resulting in the break in the outer catheter and other damage to the device. However, the definitive root cause for the difficulty removing the stylet and guard from the device could not be determined based upon available information. Labeling review: the current ifu (instructions for use) states: dilatation catheter preparation: remove the balloon guard and stylet by grasping the balloon catheter just proximal to the balloon and with the other hand, gently grasp the balloon protector and slide distally off of the balloon catheter.
 
Event Description
It was reported that upon opening the package, in preparation for the angioplasty procedure, the balloon stylet allegedly could not be removed. It was further reported that another pta catheter was used to perform the procedure. There was no patient contact.
 
Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer. 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.
 
Event Description
It was reported that upon opening the package, in preparation for the angioplasty procedure, the balloon stylet allegedly could not be removed. It was further reported that another pta catheter was used to perform the procedure. There was no patient contact.
 
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Brand NameULTRAVERSE 014 PTA BALLOON DILATATION CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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 Key6874596
MDR Text Key252962061
Report Number2020394-2017-01169
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,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/23/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Model NumberU41502H22
Device Catalogue NumberU41502H22
Device Lot NumberCMAY0552
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2016
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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