MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 3; DXE

Catalog Number	SEP3
Medical Device Problem Codes	Kinked (1339); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/17/2016
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.This report is associated with mfr report number: 3005168196-2016-01822.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using an indigo system aspiration catheter 3 (cat3) and an indigo system separator 3 (sep3).During the procedure, the physician experienced a little resistance while advancing the sep3 through the cat3 during use.Upon removal to check on the progress of the procedure, the physician noticed the sep3 and the cat3 had become kinked.Therefore, the procedure was completed using a new sep3, a new cat3, and the same non-penumbra sheath.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM SEPARATOR 3
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6171795
• Report Number: 3005168196-2016-01821
• Device Sequence Number: 1110493
• Product Code: DXE
• UDI-Device Identifier: 00814548013312
• UDI-Public: 00814548013312
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160533
• 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
• Report Date (Section B): 11/17/2016

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: 04/02/2018
• Device Catalogue Number: SEP3
• Device Lot Number: F63407
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2016
• Initial Report FDA Received Date: 12/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR