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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ATHLETIS PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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BOSTON SCIENTIFIC CORPORATION ATHLETIS PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 39347-061070
Device Problems Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2021
Event Type  malfunction  
Event Description
It was reported that foreign material was present in the device. A 6mm x 100mm athletis balloon dilatation catheter was selected for use in a shunt percutaneous transluminal angioplasty procedure. The 75% stenosed target lesion was located in moderately tortuous anatomy. The plan was to place a non-boston scientific stent. Pre-dilation was performed with a non-boston scientific guidewire and the athletis balloon. The guidewire was then removed with the athletis left in place. An attempt was made to insert a different non-boston scientific guidewire, but there was resistance in the middle, and it could not be inserted. The guidewire was exchanged for another, but there was strong resistance in the same location, and it could not be inserted. An attempt was then made to insert the original guidewire, but resistance was felt at the same location, and it could not be inserted. The athletis was removed. When it was flushed, a blue residue came out. Target treatment was completed. No patient complications were reported.
 
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Brand NameATHLETIS PTA BALLOON DILATATION CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key12302076
MDR Text Key265847652
Report Number2134265-2021-10219
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number39347-061070
Device Catalogue Number39347-061070
Device Lot Number0026825445
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/17/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/10/2021 Patient Sequence Number: 1
Treatment
AGURU SUPPORT; BESCROSS
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