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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. RIVAL PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Catalog Number RV8054
Device Problems Retraction Problem (1536); Material Rupture (1546); Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/21/2017
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 investigation summary: the device was returned for evaluation. A visual inspection identified a complete circumferential rupture in the balloon. Additionally, the balloon material was bunched at the distal tip. Stretching was noted throughout the inner guidewire lumen, and the distal marker band was dislodged due to the stretching. The distal tip of the returned sheath was slightly deformed. Based on the stretching, bunched balloon material, and damage to the returned sheath, the investigation is confirmed for the reported retraction issues. Additionally, the investigation is confirmed for a complete circumferential balloon rupture, and for a dislodged marker band. It is likely that the circumferential rupture led to the retraction issues and dislodged marker band, based on the stretched lumen, bunching of the balloon material at the distal end of the device, and damage to the users returned sheath. However, the definitive root cause for the circumferential rupture could not be determined based upon 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. Precautions: if resistance is felt during post procedure withdrawal of the catheter through the introducer sheath, determine if contrast is trapped in the balloon with fluoroscopy. If contrast is present, push the balloon out of the sheath and then completely evacuate the contrast before proceeding to withdraw the balloon. If resistance is felt during post procedure withdrawal of the catheter, it is recommended to remove the balloon catheter, introducer sheath and guidewire (as necessary) as a single unit. Use of the rival pta dilatation catheter: 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 the pta balloon allegedly ruptured. It was further reported that the balloon got stuck inside the sheath during removal. The balloon and sheath were removed together as one unit. There was no reported patient injury.
 
Manufacturer Narrative
No hospital/medical records or medical images have been made available to the manufacturer. The lot number for the device was not provided; therefore, a review of the device history records could not be performed. The return of the device is pending. The results of the anticipated device evaluation will be provided upon completion of the event investigation. 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 the pta balloon allegedly ruptured. It was further reported that the balloon got stuck inside the sheath during removal. The balloon and sheath were removed together as one unit. There was no reported patient injury.
 
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Brand NameRIVAL PTA DILATATION CATHETER
Type of DevicePTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key7196215
MDR Text Key192883248
Report Number2020394-2017-01918
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K120722
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Catalogue NumberRV8054
Device Lot NumberGFBP2253
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/03/2017
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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