MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 5; DXE

Catalog Number	SEP5
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 profunda femoris artery using an indigo system separator 5 (sep5).It was noted after a successful treatment of the superficial femoral artery (sfa) using a balloon catheter the clot shifted to the profunda femoris artery.During the procedure, after making several successful passes using the sep5 with an indigo system aspiration catheter 5 (cat5) and a non-penumbra sheath, the physician noticed the tip of the sep5 had broken off within the patient.It was reported that the physician experienced resistance while advancing and retracting the sep5.The physician then used a snare device to successfully remove the broken tip of the sep5 and decided to end the procedure.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the sep5 delivery wire was kinked approximately 32.5, 45.5, and 99.0 cm from the proximal end.The core wire was fractured approximately 173.5 cm from the proximal end.The distal fractured segment was not returned for evaluation.The wrapping wire was unraveled.Conclusions: evaluation of the returned sep5 confirmed a fracture on the distal end.If the sep5 is forcefully manipulated repeatedly through tough clot burden, the distal tip may fatigue and fracture.The distal fractured segment was not returned for evaluation.Further evaluation revealed kinks along the delivery wire and an unraveled wrapping wire.The unraveled wrapping wire was likely a result of the reported fracture.The kinks were likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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.

• Brand Name: INDIGO SYSTEM SEPARATOR 5
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8745277
• Report Number: 3005168196-2019-01284
• Device Sequence Number: 11393804
• Product Code: DXE
• UDI-Device Identifier: 00814548016108
• UDI-Public: 00814548016108
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 05/31/2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/12/2021
• Device Catalogue Number: SEP5
• Device Lot Number: F83574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 08/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Date Report Sent to FDA: 01/01/2005