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

Model Number	SEP8-A
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2019
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.This report is associated with mfr report number: 3005168196-2019-02199.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal iliac artery (iia) using an indigo system separator 8s (sep8s).It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician made several passes using the sep8 with an indigo system aspiration catheter 8 (cat8) and a non-penumbra 9f sheath.Next, the physician removed the sep8 to be flushed; however, while retracting, resistance was encountered and the sep8 distal tip was found to be kinked upon removal.The physician advanced a new sep8 and made another pass; however, while removing the sep8 to be flushed, the physician encountered the same resistance and the distal tip of the sep8 was found to be kinked upon removal.The procedure was completed using another sep8, the same cat8 and sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr.Results: the core wire and wrapping wire were fractured distal to the bulb at approximately 149.5 cm from the proximal end.The fractured distal end was not returned for evaluation.Conclusions: evaluation of the first sep8 revealed that the core wire was fractured, and the wrapping wire was unraveled distal to the bulb.If the sep8 is repeatedly manipulated through tough clot burden, damages such as these may occur.Evaluation of the second sep8 revealed that the atraumatic tip distal to the bulb was fractured.If the sep8 is repeatedly manipulated through tough clot burden, damage such as this may occur.If the core wire fractures, the wrapping wire may fatigue and fracture if the device is continued to be used.Penumbra separators are 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.This report is associated with mfr report number: 3005168196-2019-02199.

• Brand Name: INDIGO SYSTEM SEPARATOR 8
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9372157
• Report Number: 3005168196-2019-02200
• Device Sequence Number: 11318716
• Product Code: QEW
• UDI-Device Identifier: 00814548017440
• UDI-Public: 00814548017440
• Combination Product (Y/N): Y
• Initial Reporter Country: PL
• PMA/510(K) Number: K161523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019
• 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: 08/08/2021
• Device Model Number: SEP8-A
• Device Catalogue Number: SEP8
• Device Lot Number: F85177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 02/19/2020
• 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
• Patient Weight: 70
• Date Report Sent to FDA: 01/01/2005