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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY EXPRESS® LD ILIAC / BILIARY; STENT, ILIAC
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BOSTON SCIENTIFIC - GALWAY EXPRESS® LD ILIAC / BILIARY; STENT, ILIAC Back to Search Results
Model Number H74938046760750
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/13/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that balloon separation occurred.A 7.0x60x75cm express® ld iliac / biliary stent was advanced to treat a lesion.However, while inside the sheath, the balloon material came off the shaft of the catheter and it detached completely off the system.The device was retrieved without problems.The procedure was completed with another of the same device.There was no sequelae with the patient and the patient was fine.
 
Manufacturer Narrative
Device evaluated by mfr., eval summary attached, method codes, result codes, and conclusion codes updated.Device evaluated by mfr: the delivery system was returned with the stent fully detached from the balloon material and in two separate pieces.The stent was not returned for analysis.No additional information was provided in respect to the location of the stent, however further information has been requested.One section consisted on balloon, markerbands, balloon bonds and tip.The other section consisted of catheter and the hub/manifold.A visual and tactile examination identified complete detachment of the balloon material at the location of the proximal balloon bond.A microscopic examination of the proximal balloon bond and catheter noted evidence of excessive tensile force having been applied to the device.Severe stretching damage was identified on both the catheter and proximal balloon bond which had detached with the balloon material.Kinking damage was also noted on the catheter of the device.The damage noted it consistent with excessive force having been applied to the device in a pulling motion, this may have occurred during removal of the device.The balloon material was bunched up and solidified blood was noted on the outside of the material.Due to the condition of the returned device is was not possible to inflate the balloon, however a visual and microscopic examination of the balloon material identified no tears or damage.Additional analysis was performed and the balloon was submerged in water to assess if bubbles were created when the material was palpitated.As no bubbles were identified this also indicated the balloon material was undamaged.No issues were noted with the catheter, balloon bond or balloon material that could have contributed to the complaint incident.The distal balloon bond was intact and undamaged.A visual and microscopic examination identified no issues with the tip or markerbands that could 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 investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
 
Event Description
It was reported that balloon separation occurred.A 7.0x60x75cm express® ld iliac / biliary stent was advanced to treat a lesion.However, while inside the sheath, the balloon material came off the shaft of the catheter and it detached completely off the system.The device was retrieved without problems.The procedure was completed with another of the same device.There was no sequelae with the patient and the patient was fine.
 
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Brand Name
EXPRESS® LD ILIAC / BILIARY
Type of Device
STENT, ILIAC
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 Key7321306
MDR Text Key101972616
Report Number2134265-2018-01703
Device Sequence Number1
Product Code NIO
UDI-Device Identifier08714729392231
UDI-Public08714729392231
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P090003
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 02/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/12/2020
Device Model NumberH74938046760750
Device Catalogue Number38046-76075
Device Lot Number0021376052
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/13/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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