MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	26280
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	02/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: no date provided, used the first date in the month of the aware date.Implant date: no date provided, used the first date in the month of the aware date.
Event or Problem Description
It was reported that the patient experienced an allergic reaction.A 18x60 10fr 75cm wallstent endoprosthesis was placed in the patient.The patient experienced an allergic reaction.
Event or Problem Description
It was reported that the patient experienced an allergic reaction.A 18x60 10fr 75cm wallstent endoprosthesis was placed in the patient.The patient experienced an allergic reaction.It was further reported that the patient was allergic to many other things.It was confirmed that there is no longer an allegation against the wallstent as this was not what the patient was allergic to.No further information is available.
Additional Manufacturer Narrative
B3: date of event: no date provided, used the first date in the month of the aware date.D6: implant date: no date provided, used the first date in the month of the aware date.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9829612
• Report Number: 2134265-2020-03138
• Device Sequence Number: 2830249
• Product Code: JCT
• UDI-Device Identifier: 08714729204077
• UDI-Public: 08714729204077
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

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 Expiration Date: 10/27/2019
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0021308383
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 04/06/2020
• 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: Other