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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY CHARGER?; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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BOSTON SCIENTIFIC - GALWAY CHARGER?; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number H74939206090470
Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Material Rupture (1546); Torn Material (3024)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/04/2014
Event Type  Injury  
Event Description
It was reported that balloon rupture, removal difficulty, balloon tear and balloon detachment occurred.The target lesion was located in the left subclavian vein.A 9.0 x 40, 75cm charger¿ balloon catheter was advanced to the lesion.The balloon was inflated to 15 or 16 atmospheres however it ruptured.The physician tried to withdraw the device however resistance was encountered when removing through an unspecified sheath.The device was able to be withdrawn however it was noted that the balloon was completely torn in half and there was a missing section of the balloon.It was discovered via fluoroscopy that approximately 2cm of the balloon was left inside the patient.An unspecified self-expanding stent was deployed to trap the detached portion of the balloon against the vessel wall the procedure was completed using a different device.No further patient complications were reported and the patient's status was fine.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Device evaluated by mfr: a break was identified in the shaft of the returned device and the balloon was ruptured.A visual examination of the returned device identified a circumferential tear in the balloon material.The tear was identified 28mm distal to the proximal touch-up.It was noted that some of the middle section of the balloon material had detached.A visual and microscopic examination could find no issue with the profile of the devices markerbands.A visual examination confirmed that the shaft within the balloon was severely kinked 8mm proximal to the tip and at other positions along its length.This type of damage is consistent with excessive force being applied to the delivery system.This device is recommended for use in conjunction with a 6fr introducer sheath.The 7fr cordis introducer sheath used during the procedure was returned to the complaint investigation site for analysis.It was possible to remove the device through the sheath however some resistance was noted at the distal end of the device where the balloon material had been inverted.No other issues were identified during the product analysis.Based on the analysis and a review of the manufacturing documentation there is no evidence that the device failed to meet specification prior to shipping.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 balloon rupture, removal difficulty, balloon tear and balloon detachment occurred.The target lesion was located in the left subclavian vein.A 9.0 x 40, 75cm charger¿ balloon catheter was advanced to the lesion.The balloon was inflated to 15 or 16 atmospheres however it ruptured.The physician tried to withdraw the device however resistance was encountered when removing through an unspecified sheath.The device was able to be withdrawn however it was noted that the balloon was completely torn in half and there was a missing section of the balloon.It was discovered via fluoroscopy that approximately 2cm of the balloon was left inside the patient.An unspecified self-expanding stent was deployed to trap the detached portion of the balloon against the vessel wall the procedure was completed using a different device.No further patient complications were reported and the patient's status was fine.
 
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Brand Name
CHARGER?
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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 Key4308352
MDR Text Key5215018
Report Number2134265-2014-07467
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112697
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/12/2017
Device Model NumberH74939206090470
Device Catalogue Number3920609047
Device Lot Number0017361076
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/11/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/14/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNSPECIFIED SHEATH
Patient Outcome(s) Required Intervention;
Patient Age69 YR
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