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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 Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Patient Involvement (2645)
Event Date 09/24/2019
Event Type  malfunction  
Event Description
It was reported that foreign matter was present inside the packaging.An accustick was selected for use in a nephrostomy procedure.Upon unpacking the device, an eyelash was found inside the sterile packaging.The physician opened another device to complete the procedure.The patient experienced no harm as the compromised device was not used.
 
Manufacturer Narrative
Device analysis by mfr: the returned device consisted of an accustick.Only the unused guidewires were returned for analysis, both guidewires returned in its sealed pouch.The heat seal runs throughout the entire length of the pouch without any damage.One hair was observed inside the pouch.
 
Event Description
It was reported that foreign matter was present inside the packaging.An accustick was selected for use in a nephrostomy procedure.Upon unpacking the device, an eyelash was found inside the sterile packaging.The physician opened another device to complete the procedure.The patient experienced no harm as the compromised device was not used.
 
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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
MDR Report Key9199126
MDR Text Key164147783
Report Number2134265-2019-12514
Device Sequence Number1
Product Code KGZ
UDI-Device Identifier08714729201137
UDI-Public08714729201137
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2019
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 Number0024193412
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2019
Date Manufacturer Received11/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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