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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number U357588
Device Problems Detachment Of Device Component (1104); Device Damaged Prior to Use (2284); Detachment of Device or Device Component (2907)
Patient Problem No Patient Involvement (2645)
Event Date 01/11/2016
Event Type  malfunction  
Manufacturer Narrative
No medical records or no 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 during the opening of the device package, the hub was found allegedly detached from the catheter.Reportedly, another pta balloon catheter was used to complete the procedure.There was no reported patient involvement.
 
Manufacturer Narrative
Manufacturing review: a manufacturing review was conducted.The lot met all release criteria.Visual/microscopic inspection: the sample was returned clean.The balloon was in its original folded configuration with the balloon guard and stylet still in place.The balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 8mm x 80mm balloon.The proximal segment contained the hub and the strain relief.The distal segment contained the rest of the catheter and the balloon.No other anomalies were noted to the catheter.Performance/functional evaluation: the strain relief was removed from the hub.The catheter detachment underneath the strain relief was examined under magnification and the edges of the detachment were jagged.The catheter detachment was located 0.2cm from the distal end of the y-hub.Sanding marks were noted on the catheter at the point of the detachment.No functional testing could be performed due to the condition in which the sample was returned (i.E.Catheter detachment).Medical records review: as medical records were not provided, a review could not be performed.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the investigation is confirmed for a complete circumferential catheter shaft break just distal to the y-hub.Excessive sanding of the catheter under the strain relief is the root cause for the catheter detachment.Labeling review: the current ifu (instructions for use) states: precautions: carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape, and condition are suitable for the procedure for which it is to be used.Do not use if product damage is evident.Use of the ultraverse 035 pta dilatation catheter: position the balloon relative to the lesion to be dilated, ensure the guidewire is in place, and inflate the balloon to the appropriate pressure.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.
 
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Brand Name
ULTRAVERSE 035 PTA BALLOON DILATATION CATHETER
Type of Device
PTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 west 3rd st.
tempe AZ 85281
Manufacturer (Section G)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford
EI  
Manufacturer Contact
judith ludwig
1625 west 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key5433767
MDR Text Key38695795
Report Number2020394-2016-00175
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K142261
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 01/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2016
Device Catalogue NumberU357588
Device Lot Number50116143
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/18/2016
Initial Date FDA Received02/12/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/11/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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