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

Catalog Number	SEP8
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2017
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 hospital disposed of the device.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using an indigo system separator 8 (sep8).During the procedure, the physician successfully used the sep8 with an indigo system aspiration catheter 8 (cat8) to remove thrombus.While retracting the sep8, the technologist encountered resistance as there was clot all around the sep8 bulb and into the rotating hemostasis valve (rhv).After removal, the physician noticed that the sep8 bulb was missing yet the wire was intact.It was believed that the sep8 bulb was aspirated.There was still a small amount of clot remaining in the patient.Therefore, the physician completed the procedure using just 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: 6449392
• Report Number: 3005168196-2017-00502
• Device Sequence Number: 19177026
• Product Code: DXE
• UDI-Device Identifier: 00814548016153
• UDI-Public: 00814548016153
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/03/2017

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: 12/22/2018
• Device Catalogue Number: SEP8
• Device Lot Number: F66999
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2017
• Initial Report FDA Received Date: 03/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR