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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY BLUE MAX¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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BOSTON SCIENTIFIC - GALWAY BLUE MAX¿; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number M001125630
Device Problems Detachment Of Device Component (1104); Torn Material (3024)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/11/2015
Event Type  Injury  
Event Description
It was reported that balloon detachment and circumferential balloon tear occurred.The target lesion was located in the upper arm cephalic vein.A 9-8/5.8/40 blue max¿ balloon catheter was selected and advanced.The balloon was inflated at nominal pressure; however, circumferential balloon tear was noted.Upon removal of the device, it was noted that a portion of the balloon sheared off and was lodged within the treated vein.The procedure was completed with the implantation of a stent to jail the detached balloon and dilation was performed using a non-bsc balloon catheter.No further patient complications were reported and the patient's status was good and stable.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Device evaluated by mfr: a visual examination of the returned device identified that a complete balloon circumferential tear was present in the balloon.The tear was located at 4.7cm distal to the distal edge of the proximal markerband.The distal section of the balloon material tear was not received for analysis.No breaks were present in the shaft.A microscopic examination of the balloon material and proximal and distal markerbands identified no issues which could potentially have contributed to the tear.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 detachment and circumferential balloon tear occurred.The target lesion was located in the upper arm cephalic vein.A 9-8/5.8/40 blue max¿ balloon catheter was selected and advanced.The balloon was inflated at nominal pressure; however, circumferential balloon tear was noted.Upon removal of the device, it was noted that a portion of the balloon sheared off and was lodged within the treated vein.The procedure was completed with the implantation of a stent to jail the detached balloon and dilation was performed using a non-bsc balloon catheter.No further patient complications were reported and the patient's status was good and stable.
 
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Brand Name
BLUE MAX¿
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 Key4814964
MDR Text Key5895267
Report Number2134265-2015-03361
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K972357
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative,company representative
Reporter Occupation Other
Type of Report Initial
Report Date 05/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/08/2018
Device Model NumberM001125630
Device Catalogue Number12-563
Device Lot Number0017588408
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received08/14/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/12/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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