• 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 018 PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

  • 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 018 PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number U357554
Device Problems Material Rupture (1546); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
A complete manufacturing review could not be conducted as the investigation is lot number unknown. Conclusion: the device was returned. A visual inspection found the device returned in two segments. A complete circumferential rupture was noted in the balloon. Additionally, the distal portion of the inner guidewire lumen and distal portion of the balloon was returned detached. Therefore, the investigation is confirmed for both a circumferential balloon rupture and catheter detachment. The investigation is also confirmed for dislodged marker bands, as both marker bands were dislodged and able to move freely along the guidewire lumen. Per the reported event details, the procedure was being conducted in a heavily calcified lesion in the superficial femoral artery. Therefore, it is possible that patient factors contributed to the identified rupture. The balloon rupture likely led to the catheter detachment during balloon removal. However, the definitive root cause for the rupture could not be determined based on the available information. Labeling review: the current ifu (instructions for use) states: warnings: when the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated. If resistance is met during manipulation, determine the cause of the resistance before proceeding. Applying excessive force to the catheter can result in tip breakage or balloon separation. Do not exceed the rbp recommended for this device. Balloon rupture may occur if the rbp rating is exceeded. To prevent over pressurization, use of a pressure monitoring device is recommended. Use of the ultraverse 018 pta balloon 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 apply negative pressure to fully evacuate fluid from the balloon. Confirm that the balloon is fully deflated under fluoroscopy and that no contrast is left in the balloon. While maintaining negative pressure and the position of the guidewire, grasp the balloon catheter just outside the sheath and withdraw the deflated dilatation catheter over the wire through the introducer sheath. Use of a gentle counterclockwise motion may be used to help facilitate catheter removal through the introducer sheath.
 
Event Description
It was reported that during an angioplasty procedure of a heavily calcified lesion in the sfa the pta balloon allegedly ruptured. After the rupture occurred the distal portion of the balloon circumferentially detached inside the patient. Reportedly, as the original guidewire was being removed from the patient, the distal portion of the balloon was attached to the guidewire and was able to be removed successfully. The health care provider was able to successfully deploy a stent at the lesion site to complete the procedure.
 
Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer. The lot number for the device was provided. The device history records are currently under review. The return of the device is pending. The investigation is currently under way. 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 of a heavily calcified lesion in the sfa the pta balloon allegedly ruptured. After the rupture occurred the distal portion of the balloon circumferentially detached inside the patient. Reportedly, as the original guidewire was being removed from the patient, the distal portion of the balloon was attached to the guidewire and was able to be removed successfully. The health care provider was able to successfully deploy a stent at the lesion site to complete the procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameULTRAVERSE 018 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 Key6638685
MDR Text Key250669048
Report Number2020394-2017-00613
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K121856
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/03/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2019
Device Model NumberU357554
Device Catalogue NumberU87556
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/06/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-