MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMPLIANCE ENDOKIT; CONVENIENCE KIT

Model Number	CEK-880-20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	04/05/2019
Type of Reportable Event	Serious Injury
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).According to the complainant, the suspect device has been disposed and is not available for return; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a compliance endokit was used on (b)(6) 2019.According to the complainant, during preparation, when the technician opened the kit, there were overwhelming fumes which caused the technician to have an allergic reaction.The technician was taken to the emergency room.It is unknown as to what treatment was given to the technician in the emergency room however they were reported to be fine and stable following treatment.There was no patient involvement with this event.

• Brand Name: COMPLIANCE ENDOKIT
• Common Device Name: CONVENIENCE KIT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8566835
• Report Number: 3005099803-2019-02296
• Device Sequence Number: 16772035
• Product Code: MNL
• UDI-Device Identifier: 00840253115157
• UDI-Public: 00840253115157
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CEK-880-20
• Device Catalogue Number: 2088-06
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization