MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GREENFIELD; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	43175
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	08/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event date was reported as (b)(6) 2020.
Event or Problem Description
It was reported that the device broke and became detached.A greenfield filter was attempted to be implanted in (b)(6) 2020.During the procedure the dilator that was used to introduce the device broke off in the patients vessel.The physician had to open the patient up in order to retrieve the broken piece and to complete the procedure.No patient complications were reported.
Event or Problem Description
It was reported that the device broke and became detached.A greenfield filter was attempted to be implanted in (b)(6) 2020.During the procedure the dilator that was used to introduce the device broke off in the patients vessel.The physician had to open the patient up in order to retrieve the broken piece and to complete the procedure.No patient complications were reported.Update: reported via user facility medwatch # (b)(4).
Additional Manufacturer Narrative
B3: event date was reported as (b)(6) 2020.Correction: b1 was updated from product problem to adverse event and product problem.B2 was updated from other to required intervention.H1 was updated from malfunction to serious injury.B5: added user facility medwatch # (b)(4).

• Brand Name: GREENFIELD
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10655830
• Report Number: 2134265-2020-13903
• Device Sequence Number: 2767240
• Product Code: DTK
• UDI-Device Identifier: 08714729114659
• UDI-Public: 08714729114659
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K901659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/02/2020
• Device Model Number: 43175
• Device Catalogue Number: 43175
• Device Lot Number: 0021331731
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 12/17/2020
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 69