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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 M001BP90720B0
Device Problems Balloon (419); Cutter/Blade (777); Detachment Of Device Component (1104); Material Puncture/Hole (1504)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Event Description

It was reported that a blade detachment occurred. A 7. 00mm/2. 0cm/90cm otw peripheral cutting balloon¿ was selected for treatment. During procedure, when the device was removed from the patient, it was noted that two arms broke puncturing the balloon and one of the blades was detached. They were able to recover all parts upon removal of the sheath. There were no patient complications reported.

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

Device evaluated by manufacturer. The device was returned for analysis. A visual examination identified that approximately 15 mm of one blade and blade pad had lifted from the balloon's proximal body. However, 3. 5 mm of the proximal section of the blade pad was still intact. Additionally, approximately 5 mm of one blade and blade pad had lifted from the balloon's proximal body. However, 1 mm of the proximal section of the blade pad was still intact. Also, an entire blade and blade pad had detached from the balloon. It was noted that the balloon was not folded which subjected to positive pressure. Blood was identified within the balloon and inflation lumen which is evidence of a device leak. The device was attached to an encore inflation unit. Positive pressure was applied when a leak was noted. A further microscopic analysis noted a pinhole at 1. 5 mm proximal to the proximal end of the distal markerband. A visual and tactile examination found that the hypotube was kinked at various positions along its length. This type of damage is consistent with excessive force being applied to the delivery system during device use/handling. No further damage was noted to the catheter. 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 blade detachment occurred. A 7. 00mm/2. 0cm/90cm otw peripheral cutting balloon¿ was selected for treatment. During procedure, when the device was removed from the patient, it was noted that two arms broke puncturing the balloon and one of the blades was detached. They were able to recover all parts upon removal of the sheath. There were no patient complications reported.

 
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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 Key4481199
MDR Text Key5331485
Report Number2134265-2015-00758
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK070951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/09/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/03/2015
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 NumberM001BP90720B0
Device Catalogue NumberBP907020B
Device LOT Number0017314904
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/19/2015
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/10/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/13/2014
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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