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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLSTENT-UNI¿ ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE
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BOSTON SCIENTIFIC - GALWAY WALLSTENT-UNI¿ ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE Back to Search Results
Model Number M001731360
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/19/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that tip detachment occurred.The target lesion was located in a portal vein.After a 10f introducer sheath was inserted, and a 9f non-bsc sheath and 0.035 amplatz guide wire were advanced, a 10 x 68mm x 75cm wallstent-uni¿ endoprosthesis was advanced to treat the lesion.However, the stent delivery system became stuck inside the sheath.Subsequently, the device was removed from the patient's body together with the sheath.During removal of the device from the 9f sheath outside the patient's body, it was noted that the tip of the device was lost inside the sheath.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The device fit through the lab 7fr introducer sheath without issue.A visual and tactile examination identified slight damage at the distal end of the outer.The investigator was unable to see the tip.The investigator was unable to deploy the outer to expose the tip.The distal end of the device was dissected and the investigator confirmed that both the tip and stent were present on the device.The tip had been retracted into the outer.Multiple kinks were also observed along the length of the outer.This type of damage is consistent with the application of excessive force to the delivery system either during the procedure or by handling.No other issues were identified during the product analysis.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 tip detachment occurred.The target lesion was located in a portal vein.After a 10f introducer sheath was inserted, and a 9f non-bsc sheath and 0.035 amplatz guide wire were advanced, a 10 x 68mm x 75cm wallstent-uni¿ endoprosthesis was advanced to treat the lesion.However, the stent delivery system became stuck inside the sheath.Subsequently, the device was removed from the patient's body together with the sheath.During removal of the device from the 9f sheath outside the patient's body, it was noted that the tip of the device was lost inside the sheath.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
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Brand Name
WALLSTENT-UNI¿ ENDOPROSTHESIS
Type of Device
PROSTHESIS, TRACHEAL, EXPANDABLE
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 Key6794938
MDR Text Key82813044
Report Number2134265-2017-07851
Device Sequence Number1
Product Code JCT
Combination Product (y/n)N
Reporter Country CodeRO
PMA/PMN Number
K992510
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/21/2019
Device Model NumberM001731360
Device Catalogue Number73-136
Device Lot Number0020550629
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age56 YR
Patient Weight65
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