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

Model Number	SEP8-A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using an indigo system separator 8 (sep8), indigo system aspiration catheter 8 (cat8) and, a non-penumbra sheath.During the procedure, after using the sep8 and cat8 in the target vessel for approximately 10 minutes, the physician removed the sep8 and found the distal tip to be kinked.The procedure was completed using the same cat8, sheath and balloon angioplasty.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the sep8 core wire was fractured and the wrapping wire on the core wire was stretched approximately 149.5 cm from the proximal end.Conclusions: evaluation of the returned sep8 revealed that the core wire was fractured and the wrapping wire on the core wire was stretched.If the sep8 is repeatedly manipulated against tough clot burden, the distal tip my become fatigue and the core wire may fracture.Further manipulation may result in the wrapping wire stretching.During the functional test, the returned sep8 was advanced through a demonstration cat8 without an issue.Penumbra separators are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: INDIGO SYSTEM SEPARATOR 8
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9729828
• Report Number: 3005168196-2020-00227
• Device Sequence Number: 2460558
• Product Code: QEW
• UDI-Device Identifier: 00814548017440
• UDI-Public: 00814548017440
• Combination Product (Y/N): Y
• Initial Reporter State: OK
• 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,Followup
• Report Date (Section B): 01/29/2020
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: SEP8-A
• Device Catalogue Number: SEP8
• Device Lot Number: F92206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR
• Date Report Sent to FDA: 01/01/2005