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

Model Number	SEP8-A
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2020
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 numbers: 3005168196-2020-01733, 3005168196-2020-01735.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the femoral, popliteal and trifurcation arteries using an indigo system separator 8 (sep8), an indigo system aspiration catheter 8 (cat8), a non-penumbra sheath, a non-penumbra catheter and an indigo system aspiration catheter 6 (cat6).During the procedure, the physician completed three passes using the cat8 and sep8.During the fourth pass, the physician experienced resistance while aspirating the clot in the femoral artery using the cat8 and sep8.Subsequently, the distal end of the cat8 kinked and the distal end of the sep8 bent then stretched.Therefore, the sep8 and cat8 were removed.Next, the physician experience resistance while attempting to aspirate thrombus in the trifurcation artery using the cat6 without a separator.Subsequently, the distal end of the cat6 kinked and therefore it was removed.The physician continued the procedure using a non-penumbra catheter but encountered difficulties due to the thrombus being chronic.The procedure was completed using the same sheath and catheter.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM SEPARATOR 8
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10708491
• Report Number: 3005168196-2020-01734
• Device Sequence Number: 3456992
• Product Code: QEW
• UDI-Device Identifier: 00814548017440
• UDI-Public: 00814548017440
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 09/23/2020
• 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: 06/09/2022
• Device Model Number: SEP8-A
• Device Catalogue Number: SEP8
• Device Lot Number: F90909
• 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: 09/23/2020
• Initial Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005