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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
Catalog Number AT75144
Device Problems Bent (1059); Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 03/22/2017
Event Type  malfunction  
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 device was 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 preparation for a balloon angioplasty procedure, an alleged break was identified at the balloon-catheter butt joint of the pta balloon catheter. Reportedly, another balloon was used to complete the procedure. There was no patient contact.
 
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 event reported to date for this lot number and failure mode. Visual inspection: the device was returned with the balloon guard still in place and with the product label. The balloon size for this product was printed on the balloon hub of the catheter and identified the returned sample as a 14mm x 4cm balloon. A partial circumferential outer shaft break was observed at the proximal balloon glue joint. The inner polyimide was noted to be intact. The break was examined under microscopic magnification (30x) and there were no obvious signs of stretching observed. The edges of the outer shaft break were found jagged, indicating that the break was not clean. The distal end of the balloon was found bent in the balloon guard. Functional/performance evaluation: a functional evaluation was not performed due to the break in the device. Medical records review: medical records were not provided for review. Image/photo review: images/photos were not provided for review. Conclusion: the device was returned. The device was examined and a complete circumferential break was found at the glue joint confirming the investigation for a break. The investigation was also confirmed for a bend as the distal end of the balloon was found bent. The definitive root cause for the identified break or bend could not be determined based upon available information. It was unknown if procedural issues contributed to the event. Labeling review: the current ifu (instructions for use) states: precautions: carefully inspect the catheter prior to use to verify that catheter has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used. Do not use if product damage is evident. Do not continue to use the balloon catheter if the shaft has been bent or kinked. Dilatation catheter preparation: remove catheter from package. Verify the balloon size is suitable for the procedure and the selected accessories accommodate the catheter as labeled. Remove the balloon guard by grasping the balloon catheter just proximal to the balloon and with the other hand, gently grasp the balloon protector and slide distally off of the balloon catheter. - 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 preparation for a balloon angioplasty procedure, an alleged break was identified at the balloon-catheter butt joint of the pta balloon catheter. Reportedly, another balloon catheter was used to complete the procedure. There was no patient contact.
 
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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 Key6509193
MDR Text Key73348436
Report Number2020394-2017-00352
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 health professional,user faci
Reporter Occupation Radiologic Technologist
Type of Report Initial,Followup
Report Date 06/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2020
Device Catalogue NumberAT75144
Device Lot NumberGFBN3379
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/24/2017
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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