MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 6; DXE

Model Number	SEP6
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2020
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the anterior popliteal artery and the anterior tibial artery using an indigo system aspiration catheter 6 (cat6), an indigo system separator 6 (sep6), a non-penumbra guiding sheath, and a guidewire.During the procedure, the physician advanced the cat6 over the guidewire, through the sheath and into the target location.The guidewire was then removed and the sep6 was advanced through the cat6 and into the target location.Next, the physician completed the first pass.During the second pass, the physician noticed via an angiography that while the sep6 was being advanced in and out of the cat6, the sep6 was unable to advance through the occlusion and subsequently, the sep6 folded on itself inside the cat6.Therefore, the sep6 and cat6 were removed together.After the removal, it was noticed that the bulb of the sep6 broke but remained attached to the pusher wire.Afterwards, the physician advanced a new sep6 with the cat6 to attempt to engage the thrombus; however, it was unsuccessful.Therefore, the sep6 and cat6 were removed.The physician completed the procedure by performing a percutaneous transluminal angioplasty (pta) using four balloon catheters.It was also reported that the patient became unstable at one point during the procedure, however, there was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM SEPARATOR 6
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10801973
• Report Number: 3005168196-2020-01910
• Device Sequence Number: 11712242
• Product Code: DXE
• UDI-Device Identifier: 00814548016146
• UDI-Public: 00814548016146
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K160533
• 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): 10/09/2020
• 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: SEP6
• Device Catalogue Number: SEP6
• Device Lot Number: F92201
• 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: 10/09/2020
• Initial Report FDA Received Date: 11/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Date Report Sent to FDA: 01/01/2005