MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 12; QEW

Model Number	SEP12-A
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2020
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: 3005168196-2020-01872.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the pulmonary artery using an indigo system aspiration catheter 12 (cat12), indigo system separator 12 (sep12), and non-penumbra sheath.During the procedure, the physician accessed the target vessel using the sheath.An angiogram was performed, which showed a lot of clot was present.Subsequently, the physician decided to use the sep12, but the sep12 would not advance into the opened rotating hemostasis valve (rhv), and the distal end of the sep12 was inadvertently kinked.Therefore, the rhv and sep12 were removed.The procedure was completed using a new rhv and sep12 and the same cat12.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM SEPARATOR 12
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10767102
• Report Number: 3005168196-2020-01873
• Device Sequence Number: 3509932
• Product Code: QEW
• UDI-Device Identifier: 00815948021556
• UDI-Public: 00815948021556
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K200771
• 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): 10/08/2020
• 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: 07/16/2023
• Device Model Number: SEP12-A
• Device Catalogue Number: SEP12
• Device Lot Number: F98943
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 10/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Date Report Sent to FDA: 01/01/2005