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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 M001BP90620B0
Device Problems Cutter/Blade (777); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/09/2015
Event Type  Malfunction  
Event Description

It was reported that a blade was coming off the balloon. A 6. 00mm x 2. 00cm x 90 cm peripheral cutting balloon® was selected and advanced to treat the target lesion. During removal of the device, it was noted that the blade was coming off the balloon. The procedure was completed with this device. No patient complications were reported and patient's condition is stable.

 
Manufacturer Narrative

(b)(4). Device evaluated by mfr: the device has not been received for analysis. Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).

 
Manufacturer Narrative

Device evaluated by mfr. : the device was returned for evaluation. A visual and microscopic examination identified that the entire length of the blade detached from the balloon. The blade pad was also fully detached. The detached blade/pad was returned in a separate vial. This damage can potentially be a result of the resistance encountered during the advancement or withdrawal of the device. The remaining blades were fully bonded to the balloon and no damage was noted to the other blades. There multiple kinks noted along the length of the shaft. This type of damage is consistent with excessive force being applied to the delivery system during device use. 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 a blade was coming off the balloon. A 6. 00mm x 2. 00cm x 90 cm peripheral cutting balloon was selected and advanced to treat the target lesion. During removal of the device, it was noted that the blade was coming off the balloon. The procedure was completed with this device. No patient complications were reported and patient's condition is stable.

 
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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 Key4891898
MDR Text Key6542404
Report Number2134265-2015-04412
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeAU
PMA/PMN NumberK070951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/09/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/06/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberM001BP90620B0
Device Catalogue NumberBP906020B
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/25/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2016
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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