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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCUSTICK II; INTRODUCER, CATHETER
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BOSTON SCIENTIFIC CORPORATION ACCUSTICK II; INTRODUCER, CATHETER Back to Search Results
Model Number 35615
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/21/2022
Event Type  malfunction  
Event Description
It was reported that a break/fracture occurred.A.038 j accustick ii was selected for use.During procedure, it was noted that the device was broken/fractured while inside the patient.The procedure was completed with another of same device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: the returned device matches with upn provided by the customer.An introducer sheath, metal cannula and sheath dilator were returned for analysis.Visual inspection revealed the distal tip of the sheath dilator was torn by an unknown metal wire.The metal cannula was kinked.No other issues or damage were observed.
 
Event Description
It was reported that a break/fracture occurred.A.038 j accustick ii was selected for use.During procedure, it was noted that the device was broken/fractured while inside the patient.The procedure was completed with another of same device.No patient complications were reported.
 
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Brand Name
ACCUSTICK II
Type of Device
INTRODUCER, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key14458527
MDR Text Key292188791
Report Number2134265-2022-05595
Device Sequence Number1
Product Code KGZ
UDI-Device Identifier08714729157588
UDI-Public08714729157588
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number35615
Device Catalogue Number35615
Device Lot Number0028653061
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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