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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 KS-16-20
Medical Device Problem Code Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 12/01/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the expiration and device manufacture dates are unknown.(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 an unknown date.According to the complainant, when the kit was opened, there was a long hair inside.It was not reported how the procedure was completed.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 Key8224168
Report Number3005099803-2018-62490
Device Sequence Number13851143
Product Code MNL
UDI-Device Identifier00816849015835
UDI-Public00816849015835
Combination Product (Y/N)N
Initial Reporter StateTX
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) 01/07/2019
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 Model NumberKS-16-20
Device Catalogue Number2088-08
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/14/2018
Initial Report FDA Received Date01/07/2019
Patient Sequence Number1
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