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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 M001BP90520B0
Device Problems Cutter/Blade (777); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/14/2017
Event Type  Malfunction  
Manufacturer Narrative

Age at time of event: 18 years or older. (b)(4).

 
Event Description

It was reported that one-third of the balloon blade was lifted. The 80% stenosed target lesion was located in the moderately tortuous shunt limb. A 5. 00mm / 2. 0cm / 90cm otw 2cm peripheral cutting balloon¿ was selected for use. During procedure, it was noted that one-third of the blade was peeled off. The procedure was not completed due to this event. No patient complications were reported.

 
Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation. Device analysis revealed no tears or holes were identified in the balloon. The balloon was not refolded. An examination of the balloon found that 4 mm of the proximal end of the blade was lifted on the balloon. The main section of pad was still attached to the balloon. The remaining blades were inspected and no issues were noted. No issues were identified with the tip. A visual and tactile examination identified no damage along the entire length of the shaft. No other issues were identified during the product analysis. The batch number is unknown and the manufacturing records for the complaint device could not be reviewed. The most probable root cause is operational context as device performance was limited due to anatomical/procedural factors. (b)(4).

 
Event Description

It was reported that one-third of the balloon blade was lifted. The 80% stenosed target lesion was located in the moderately tortuous shunt limb. A 5. 00 mm / 2. 0 cm / 90 cm otw 2 cm peripheral cutting balloon¿ was selected for use. During procedure, it was noted that one-third of the blade was peeled off. The procedure was not completed due to this event. No patient complications were reported.

 
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Brand Name2CM PERIPHERAL CUTTING BALLOON¿
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6304341
MDR Text Key66613637
Report Number2134265-2017-00639
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
PMA/PMN NumberK070951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/17/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/06/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM001BP90520B0
Device Catalogue NumberBP905020B
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/26/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2017
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

Patient TREATMENT DATA
Date Received: 02/06/2017 Patient Sequence Number: 1
Treatment
INTRODUCER SHEATH - 6F
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