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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 Leak/Splash (1354); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/13/2015
Event Type  malfunction  
Event Description
It was reported that a shaft rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified left superficial femoral artery.A 7fr 11cm fr non-bsc introducer sheath was advanced.After a 0.18x175 non-bsc guidewire had crossed the lesion, a 6.00mm / 2.0cm / 90cm peripheral cutting balloon¿ catheter was selected for treatment.During the first inflation to 10atms for 30 seconds, it was noted that saline was leaking from the shaft due to a shaft rupture.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.
 
Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Device analysis observed no damage to the tip, balloon or blades of the device.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A visual and tactile examination found that the shaft was damaged between 590mm and 596mm from the hub.This type of damage is consistent with excessive force being applied to the delivery system during device use/handling.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from the damaged area of shaft.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 a shaft rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified left superficial femoral artery.A 7fr 11cm fr non-bsc introducer sheath was advanced.After a 0.18x175 non-bsc guidewire had crossed the lesion, a 6.00mm / 2.0cm / 90cm peripheral cutting balloon¿ catheter was selected for treatment.During the first inflation to 10atms for 30 seconds, it was noted that saline was leaking from the shaft due to a shaft rupture.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.
 
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Brand Name
2CM PERIPHERAL CUTTING BALLOON¿
Type of Device
CATHETER, 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 Key4839734
MDR Text Key5869900
Report Number2134265-2015-03620
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K070951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,company representati
Reporter Occupation Other
Type of Report Initial
Report Date 05/14/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/25/2016
Device Model NumberM001BP90620B0
Device Catalogue NumberBP906020B
Device Lot Number0017314905
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/14/2015
Initial Date FDA Received06/11/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/21/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDEWIRE:TREASURE FLOPPY 018×175 ASAHI INTECC
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