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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMPLIANCE ENDOKIT; CONVENIENCE KIT
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BOSTON SCIENTIFIC CORPORATION COMPLIANCE ENDOKIT; CONVENIENCE KIT Back to Search Results
Model Number CEK-799-20
Medical Device Problem Code Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/30/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event or Problem Description
It was reported to boston scientific corporation that a compliance endokit was used on (b)(6) 2018.According to the complainant, when the kit was opened, there was a small bug inside the package.The kit was disposed and another compliance endokit was used to complete the procedure.There was no serious injury nor adverse patient effects reported as a result of this event.
 
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Brand Name
COMPLIANCE ENDOKIT
Common Device Name
CONVENIENCE KIT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
100 boston scientific way
marlborough MA 01752 1242
MDR Report Key8102482
Report Number3005099803-2018-61565
Device Sequence Number1695988
Product Code MNL
UDI-Device Identifier00840253114778
UDI-Public00840253114778
Combination Product (Y/N)N
Initial Reporter StateWY
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 11/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date06/29/2020
Device Model NumberCEK-799-20
Device Catalogue Number2088-03
Device Lot Number0000228937
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/31/2018
Initial Report FDA Received Date11/26/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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