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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 M001PCB60201350
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/14/2016
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
 
Event Description
It was reported that the blade was lifted.A 2cm peripheral cutting balloon® was selected for use.Upon removal of the balloon from the patient through the access sheath, it was noted that about half the blade was lifted off from the balloon and was bent at greater than a 90 degree angle.The procedure was completed with a different cutting balloon with satisfactory results.There were no patient complications reported and the patient's condition was baseline.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the blade was lifted.A 2cm peripheral cutting balloon® was selected for use.Upon removal of the balloon from the patient through the access sheath, it was noted that about half the blade was lifted off from the balloon and was bent at greater than a 90 degree angle.The procedure was completed with a different cutting balloon with satisfactory results.There were no patient complications reported and the patient's condition was baseline.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Device analysis noted that 5mm of blade lifted on the proximal end of balloon.The blade was still attached to the balloon.The blade pad was undamaged.A visual and tactile examination found no kinks or damage along the shaft of the device.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.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 the blade was lifted.A 2cm peripheral cutting balloon was selected for use.Upon removal of the balloon from the patient through the access sheath, it was noted that about half the blade was lifted off from the balloon and was bent at greater than a 90 degree angle.The procedure was completed with a different cutting balloon with satisfactory results.There were no patient complications reported and the patient's condition was baseline.
 
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Brand Name
2CM PERIPHERAL CUTTING BALLOON®
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
Manufacturer (Section D)
BOSTON SCIENTIFIC - GALWAY
Manufacturer (Section G)
BOSTON SCIENTIFIC - GALWAY
Manufacturer Contact
linda leimer
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key5857040
MDR Text Key51484897
Report Number2134265-2016-07068
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 07/14/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/24/2016
Device Model NumberM001PCB60201350
Device Catalogue NumberPCB6020135
Device Lot Number0017488086
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/05/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/11/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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