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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON® CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

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BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON® CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number M001PCB6020900
Device Problems Cutter/Blade (777); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Event Description

A 2cm peripheral cutting balloon was returned at the complaint investigation site as an extra device and approximately 4mm of the proximal end of a blade was lifted and raised distally.

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

Device evaluated by manufacturer: during device analysis: a visual examination confirmed that approximately 4 mm of one blade and blade pad had lifted from the balloon's proximal body. The remaining blades were fully bonded to the balloon and no damage was noted to the other blades. A visual and microscopic examination observed no damage to the tip. A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure. The returned device was attached to an encore inflation unit. Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole (lengthwise) at 8 mm distal to the distal end for the proximal markerband. An examination of the markerbands identified no issues were noted. The shaft profile has no kinks or damage were noticed along the shaft of the device. No other issues were identified during product analysis. The batch number is unknown and the manufacturing records for the complaint device could not be reviewed. The most probable root cause was unable to be determined. (b)(4).

 
Event Description

A 2cm peripheral cutting balloon was returned at the complaint investigation site as an extra device and approximately 4mm of the proximal end of a blade was lifted and raised distally.

 
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Brand Name2CM PERIPHERAL CUTTING BALLOON®
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
ballybrit business park
galway
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key4863516
MDR Text Key19033383
Report Number2134265-2015-03806
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK070951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/27/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/23/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM001PCB6020900
Device Catalogue NumberPCB602090
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/27/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2015
Was Device Evaluated By Manufacturer? Yes
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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