Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 GLADIATOR¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
  • 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 GLADIATOR¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number H74939207080870
Device Problem Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the shaft cracked.The target lesion was located in the left arm.An 8.0 x 80, 75cm gladiator¿ balloon catheter was advanced for dilatation.However, during the procedure, the shaft appears to have been cracked right behind the balloon.The device was removed from the patient's body still intact and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
 
Manufacturer Narrative
Device evaluated by mfr.The complaint device was returned for analysis.The balloon was observed to be unfolded which indicates it was subjected to positive pressure.Blood was visible within the balloon which is evidence of a device leak.A visual and tactile examination identified a quantity of solidified blood at one location on the shaft the device.The returned device was attached to an encore inflation unit and positive pressure was applied, however the balloon could not be inflated due to the presence of solidified blood within the balloon and inflation lumen.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the solidified blood before further inflation attempts were made.On removal from the bath the returned device was again attached to encore inflation unit and positive pressure was applied when a pinhole leak was identified in shaft of the device approximately 620mm distal to the strain relief.This pinhole extended through both the inner and outer lumen of the shaft allowing the observed liquid to escape.Balloon inflation was not possible due to the pinhole leak identified in the shaft of the device however a microscopic examination of the balloon material identified no tears or damage that could have contributed to the complaint incident.No other damage was identified along the shaft of the device.No issues were identified with the tip or markerbands of the device which may have contributed to the complaint incident.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.Bsc id: (b)(4).Tw: (b)(4).
 
Event Description
It was reported that the shaft cracked.The target lesion was located in the left arm.An 8.0 x 80, 75cm gladiator¿ balloon catheter was advanced for dilatation.However, during the procedure, the shaft appears to have been cracked right behind the balloon.The device was removed from the patient's body still intact and the procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
GLADIATOR¿
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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 Key6649226
MDR Text Key77841194
Report Number2134265-2017-06239
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113681
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
Report Date 06/05/2017
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 Date04/02/2020
Device Model NumberH74939207080870
Device Catalogue Number3920708087
Device Lot Number20483169
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/13/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/05/2017
Initial Date FDA Received06/17/2017
Supplement Dates Manufacturer Received07/13/2017
Supplement Dates FDA Received07/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/04/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-