MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2D HELICAL - 35; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	82885
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the coil was expired.On (b)(6) 2018, a 6mmx 40mm 2d helical - 35 that has an expiration date of 31jul2018 was implanted in the patient.No patient complications were reported.

• Brand Name: 2D HELICAL - 35
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8102964
• Report Number: 2134265-2018-63196
• Device Sequence Number: 19266055
• Product Code: KRD
• UDI-Device Identifier: 08714729237259
• UDI-Public: 08714729237259
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K102714
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• 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 Date: 07/31/2018
• Device Model Number: 82885
• Device Catalogue Number: 82885
• Device Lot Number: 0018163994
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 11/26/2018
• Patient Sequence Number: 1