• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC - GALWAY 2CM PERIPHERAL CUTTING BALLOON¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number M001BP90620B0
Device Problems Deflation Problem (1149); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older. (b)(4).
 
Event Description
It was reported that the sheath became torn. The target lesion was located in the moderately tortuous shunt of the limb. A 2cm peripheral cutting balloon¿ was selected for use. Upon removal of the cutting balloon, it was noted that the sheath was torn vertically. Deflation was then performed slowly. The procedure was not completed due to this event. No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis. The returned device was received together with customers introducer sheath. A visual examination identified that the shaft of the customers introducer sheath was split along its entire length. This type of damage is consistent with attempting to withdraw the device before the balloon was completely deflated. An examination of the returned device identified that the balloon had been inflated and was not refolded. The balloon and blades of the device were visually and microscopically examined and no issues were noted that may have potentially contributed to the complaint incident. All blades were present and fully bonded to the balloon surface. The investigator inflated the balloon to its rate of burst pressure 10 atmospheres to observe inflation and then applied a vacuum to observe deflation of the balloon. Both inflation and deflation were hindered due to a severe kink on the shaft of the device. No other issues were noted which may have potentially contributed to the complaint incident. A visual and tactile examination found that the shaft was severely kinked at approximately 23mm proximal of the proximal balloon bond. This type of damage is consistent with excessive force being applied to the delivery system. No other issues were noted which may have potentially contributed to the complaint incident. Product analysis identified no evidence that the sheath of the pcb device was ripped/ split. A visual and microscopic examination found no issue with the markerbands. No issues were noted with the tip section 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 investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited. (b)(4).
 
Event Description
It was reported that the sheath became torn. The target lesion was located in the moderately tortuous shunt of the limb. A 2cm peripheral cutting balloon was selected for use. Upon removal of the cutting balloon, it was noted that the sheath was torn vertically. Deflation was then performed slowly. The procedure was not completed due to this event. No patient complications were reported and the patient's status was stable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7396204
MDR Text Key104571546
Report Number2134265-2018-02574
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 company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/06/2019
Device Model NumberM001BP90620B0
Device Catalogue NumberBP906020B
Device Lot Number0021098074
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/06/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-