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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 M001BP50620B0
Device Problems Balloon (419); Cutter/Blade (777); Material Rupture (1546); Physical Resistance (2578); Material Deformation (2976); Catheter (3038)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/22/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that a part of the blade have peeled off and some discoloration on the surface of the blade was noted. The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified shunt vein. A 6. 00mm / 2. 00cm peripheral cutting balloon¿ was selected for use. During the procedure, the target lesion was approached using an unspecified 7f sheath. Dilatation was performed 4 times up to 10 atmosphere pressure using the 6. 00mm / 2. 00cm peripheral cutting balloon¿. A leak of contrast media occurred from the part of the balloon and it was suspected that the balloon ruptured due to pinhole. The balloon was carefully removed from the patient as resistance was encountered. It was suspected that the balloon got caught by the tip part of the sheath. The balloon catheter was checked after it was successfully removed from the patient. It was noted that a part of the blade have peeled off as it opens its mouth toward the balloon tip. In addition, there was something discoloration found adhesive surface of the blade. The procedure was completed with another of the same device. No patient complications were reported and patient's status was good.

 
Manufacturer Narrative

Device evaluated by mfr. : the device was returned for analysis. A detailed microscopic examination of the balloon identified a pinhole in the balloon material. The pinhole in the balloon material was located approximately 3mm proximal to the distal markerband. Approximately 6mm of the proximal section of a blade and approximately 3mm of the pad was lifted on the balloon. The blade was not detached. The remaining blades were inspected and no issues were noted. No discoloration was observed on the blades. No issues were identified with the distal 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 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 part of the blade have peeled off and some discoloration on the surface of the blade was noted. The 90% stenosed target lesion was located in the mildly tortuous and mildly calcified shunt vein. A 6. 00mm / 2. 00cm peripheral cutting balloon¿ was selected for use. During the procedure, the target lesion was approached using an unspecified 7f sheath. Dilatation was performed 4 times up to 10 atmosphere pressure using the 6. 00mm / 2. 00cm peripheral cutting balloon¿. A leak of contrast media occurred from the part of the balloon and it was suspected that the balloon ruptured due to pinhole. The balloon was carefully removed from the patient as resistance was encountered. It was suspected that the balloon got caught by the tip part of the sheath. The balloon catheter was checked after it was successfully removed from the patient. It was noted that a part of the blade have peeled off as it opens its mouth toward the balloon tip. In addition, there was something discoloration found adhesive surface of the blade. The procedure was completed with another of the same device. No patient complications were reported and patient's status was good.

 
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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 Key6177458
MDR Text Key62541564
Report Number2134265-2016-11396
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 11/22/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/15/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date06/10/2018
Device MODEL NumberM001BP50620B0
Device Catalogue NumberBP506020B
Device LOT Number0019357424
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/28/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/13/2016
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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