MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 8; DXE

Catalog Number	SEP8
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The device was discarded by the hospital.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using an indigo system separator 8 (sep8).During the procedure, while attempting to insert a sep8 through an indigo aspiration system catheter 8 (cat8) rotating hemostasis valve (rhv), the physician inadvertently bent the distal tip of the sep8.Therefore, the sep8 was removed.The procedure was completed using a new sep8 and the same cat8 without any issue.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM SEPARATOR 8
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6572810
• Report Number: 3005168196-2017-00753
• Device Sequence Number: 624060
• Product Code: DXE
• UDI-Device Identifier: 00814548016153
• UDI-Public: 00814548016153
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161523
• 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): 04/19/2017

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: Physician
• Device Expiration Date: 05/10/2019
• Device Catalogue Number: SEP8
• Device Lot Number: F69268
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2017
• Initial Report FDA Received Date: 05/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR