MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 3; DXE

Catalog Number	SEP3
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the sep3 atraumatic tip from fractured off the delivery wire approximately 189.5 cm from the proximal end.Conclusions: evaluation of the returned sep3 revealed that the atraumatic tip was fractured distal to the bulb.If the device is forcefully manipulated during use the core wire may become fatigued.If the fatigued device is repeatedly manipulated, a fracture may occur.Penumbra separators are visually 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 radial artery using an indigo system separator 3 (sep3).During the procedure, the physician made 10 passes using the sep3 with an indigo system cat3 aspiration catheter (cat3) and a non-penumbra sheath.While retracting the sep3, the physician noticed that approximately 10 millimeters of the distal tip of the sep3 had broken off and was stuck in the remaining clot.Therefore, the cat3 and sep3 were removed.The physician then advanced an indigo system cat5 aspiration catheter (cat5) and successfully aspirated and removed the broken tip of the sep3.The procedure was completed using the same cat5 and sheath.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM SEPARATOR 3
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9173476
• Report Number: 3005168196-2019-01919
• Device Sequence Number: 2323168
• Product Code: DXE
• UDI-Device Identifier: 00814548016115
• UDI-Public: 00814548016115
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160533
• 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): 09/14/2019
• 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: 03/13/2022
• Device Catalogue Number: SEP3
• Device Lot Number: F89026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• 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: 09/14/2019
• Initial Report FDA Received Date: 10/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Date Report Sent to FDA: 01/01/2005