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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ATLAS PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BARD PERIPHERAL VASCULAR, INC. ATLAS PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number AT75142
Device Problems Peeled/Delaminated (1454); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/18/2017
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. Conclusion: the device was returned for evaluation. The balloon was examined under microscopic magnification, and the pebax was noted to be peeling on the barrel of the balloon. An inflation attempt was made, and water was seen exiting the balloon fibers at the location of the peeled pebax. The fibers were stripped, and a compound rupture was identified. Therefore, the investigation is confirmed for peeled pebax, as well as for a compound balloon rupture. It is possible that the compound rupture contributed to the identified peeled pebax. However, the definitive root cause for the compound rupture or peeling pebax could not be determined based upon the available information. It is unknown if patient and/or procedural issues contributed to the reported event. Labeling review: the current ifu (instructions for use) states: warnings: 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, it is recommended to remove the balloon catheter and guidewire/introducer sheath as a single unit. Use of the atlas pta dilatation catheter: apply negative pressure to fully evacuate fluid from the balloon. Confirm that the balloon is fully deflated under fluoroscopy. While maintaining negative pressure and the position of the guidewire, 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. (b)(4).
 
Event Description
It was reported that during an angioplasty procedure to open a central venous stenosis of a dialysis av fistula, the pta balloon allegedly ruptured on the first inflation attempt. The pta balloon was exchanged over the guidewire for another that was used to complete the procedure. There was no reported patient injury.
 
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 during an angioplasty procedure to open a central venous stenosis of a dialysis av fistula, the pta balloon allegedly ruptured on the first inflation attempt. The pta balloon was exchanged over the guidewire for another that was used to complete the procedure. There was no reported patient injury.
 
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Brand NameATLAS 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)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key7149163
MDR Text Key266780209
Report Number2020394-2017-01816
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120971
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2020
Device Model NumberAT75142
Device Catalogue NumberAT75142
Device Lot NumberGFBV0705
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2017
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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