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

Catalog Number	SEP8
Medical Device Problem Codes	Break (1069); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2017
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using an indigo system separator 8 (sep8).During the procedure, after making several passes with an indigo system aspiration catheter 8 (cat8), the physician inserted the sep8 using the introducer sheath.Resistance was experienced when the physician attempted to advance the sep8 through the hub of the cat8, therefore, the physician decided to remove the sep8.It was then noticed that the tip of the sep8 was missing.The physician performed an angiography to search for the tip; however the physician could not find it within the patient and, therefore, assumed the tip had been aspirated and was inside the canister.The procedure was then completed using the cat8.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: 6593896
• Report Number: 3005168196-2017-00798
• Device Sequence Number: 739796
• Product Code: DXE
• UDI-Device Identifier: 00814548016153
• UDI-Public: 00814548016153
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/27/2017

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: 04/26/2019
• Device Catalogue Number: SEP8
• Device Lot Number: F69087
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2017
• Initial Report FDA Received Date: 05/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR