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

Model Number	SEP8-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2020
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 in the femoral popliteal artery using an indigo system separator 8 (sep8), an indigo system aspiration catheter 8 (cat8), a non-penumbra 9f sheath introducer, and guidewire.During the procedure, the physician advanced the cat8 over the guidewire through the 9f sheath to the target site.The guidewire was then removed and the sep8 was advanced through the cat8.Next, aspiration was initiated.While advancing the sep8 in and out of the cat8, the physician noticed under fluoroscopy that the wire distal to the bulb of the sep8 was broken.Therefore, the broken sep8 was aspirated out using the cat8.No additional information regarding the completion of the procedure was provided.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the atraumatic tip was fractured distal to the bulb.Conclusions: evaluation of the returned sep8 confirmed a fractured distal atraumatic tip.If the device is repeatedly manipulated against tough clot burden, the atraumatic tip may fatigue.Subsequently, the core wire and wrapping wire may fracture if the device continues 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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the femoral popliteal artery using an indigo system separator 8 (sep8), an indigo system aspiration catheter 8 (cat8), a non-penumbra 9f sheath introducer, and a guidewire.During the procedure, the physician advanced the cat8 over the guidewire through the 9f sheath to the target site.The guidewire was then removed and the sep8 was advanced through the cat8.Next, aspiration was initiated.While advancing the sep8 in and out of the cat8, the physician noticed under fluoroscopy that the wire distal to the bulb of the sep8 was broken.Therefore, the broken sep8 was aspirated out using the cat8.The procedure was completed using the cat8.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: 9656399
• Report Number: 3005168196-2020-00123
• Device Sequence Number: 1742184
• Product Code: QEW
• UDI-Device Identifier: 00814548017440
• UDI-Public: 00814548017440
• Combination Product (Y/N): Y
• Initial Reporter Country: PE
• PMA/510(K) Number: K161523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2020
• 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: 07/15/2022
• Device Model Number: SEP8-A
• Device Catalogue Number: SEP8
• Device Lot Number: F91780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 02/01/2020
• Supplement Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Date Report Sent to FDA: 01/01/2005