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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
Catalog Number U41502H22
Device Problems Break (1069); Detachment of Device or Device Component (2907); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 03/21/2017
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. This is the only complaint reported to date for this lot number and failure mode. Visual/microscopic inspection: the balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 2. 5mm x 220mm x 150cm balloon. The device was examined under microscopic magnification and a complete circumferential break was noted on the inner lumen 33. 2cm from the distal tip, and a completed circumferential break of the outer catheter was noted at the glue joint. The inner lumen measured 119. 8cm from the strain relief to the circumferential break in the lumen; stretching was noted to the inner lumen at the point of the break. The balloon segment of the device included the distal tip, the balloon and a portion of the inner lumen. No other anomalies were noted to the bifurcate or proximal portion of the catheter. Functional/performance evaluation: functional testing was not conducted to the returned sample condition. Medical records review: medical records were not provided; therefore, a review could not be performed. Image/photo review: images/photos were not provided; therefore, a review could not be performed. Conclusion: the device was returned in two complete segments. The device was examined under microscopic magnification and breaks were noted to the inner lumen and outer catheter, with the entire balloon detached from the proximal end of the device. Therefore, the investigation is confirmed for a break and for balloon detachment. Additionally, the investigation is inconclusive for the device not looking right when removed from the packaging, as the device was returned already opened from the packaging, and as the original condition of the device could not be verified. 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 breaks in the device and the detached balloon. However, the definitive root cause for the reported issue could not be determined based upon the available information. It is unknown if procedural issues during removal of the device from the packaging contributed to the reported event. 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. Precautions: 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. Potential adverse reactions: additional intervention equipment required. Luer lock syringe/inflation device with manometer (10 ml or larger).
 
Event Description
It was reported that the device allegedly did not look right after opening the inner packaging. 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. 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 the device allegedly did not look right after opening the inner packaging. 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 Key6592962
MDR Text Key163892524
Report Number2020394-2017-00526
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,Followup
Report Date 06/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Catalogue NumberU41502H22
Device Lot NumberCMAY0514
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/29/2016
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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