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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ATLAS PTA BALLOON DILIATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number AT75164
Device Problems Material Frayed (1262); Peeled/Delaminated (1454)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/30/2017
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. Conclusion: the device was returned for evaluation. A microscopic magnification found frayed fibers on the distal cone of the balloon, as well as strands of peeled pebax. Therefore, the investigation is confirmed for frayed material, and peeled pebax. The device was inflated, and deflated with no ruptures noted in the balloon. Because the rupture could not be identified, the investigation is unconfirmed for the reported balloon rupture. The definitive root cause for the identified peeled pebax, frayed balloon fibers, or reported rupture 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. 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 in the back of the knee, the pta balloon allegedly ruptured after the second inflation attempt at nominal pressure. 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 DILIATATION 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 Key7036046
MDR Text Key92800049
Report Number2020394-2017-01571
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 user facility
Reporter Occupation
Type of Report Initial
Report Date 11/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2020
Device Model NumberAT75164
Device Catalogue NumberAT75164
Device Lot NumberGFBU3220
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/15/2017
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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