• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035 PTA CATHETER PTA DILATATION BALLOON CATHETER Back to Search Results
Catalog Number U35130512
Device Problems Break; Failure to Advance
Event Date 04/28/2016
Event Type  Malfunction  
Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event. The lot met all release criteria. Visual inspection: the balloon size for this product is printed on the balloon hub of the catheter and identified the returned sample as a 5mm x 120mm balloon. The balloon was returned in its original folded configuration. The catheter was kinked 8. 3cm, 11. 4cm, and 13. 4cm from the distal tip. However after review of the preliminary pictures, the manner in which the device was packaged for return may have contributed to the kinks. No kinks were reported by the user. No anomalies were noted to the strain relief or the y-hub. Functional/performance evaluation: the patency was tested using an in-house. 035¿ guide wire and the guide wire was unable to be advanced past the kinks in the catheter. The strain relief was removed and a partial circumferential catheter shaft break was observed at the distal end of the y-hub. Sanding marks were noted on the catheter underneath the strain relief and at the location of the break. 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. The investigation is confirmed for a partial circumferential catheter shaft break just distal to the y-hub. The investigation is inconclusive for failure to advance, as functional testing could not be performed due to the poor sample condition (i. E. Kinked catheter). Excessive sanding of the catheter under the strain relief is the root cause for the partial break in the catheter. Per the reported event details, the tracking path was mildly calcified. Therefore, it is possible that patient factors contributed to the failure to advance through the lesion. Labeling review: the current ultraverse 035 pta balloon catheter instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device. 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 pta balloon allegedly would not cross the lesion over the guidewire in the right sfa. It was further reported that there was alleged mild calcification in the tracking path; however, there was no reported difficulty in retracting the balloon through the sheath. Another balloon was reported to be used to complete the procedure. There was no reported patient injury.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameULTRAVERSE 035 PTA CATHETER
Type of DevicePTA DILATATION BALLOON 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 Key5764067
Report Number2020394-2016-00599
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 04/29/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/30/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2016
Device Catalogue NumberU35130512
Device LOT Number50112648
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/20/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2016
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

-
-