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

Catalog Number	SEP8
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2019
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 in the left popliteal vein, femoral vein, and iliac vein using an indigo system separator 8 (sep8).It was noted that the patient had a very high clot burden extending from the popliteal vein up to the bifurcation.Prior to the procedure the patient was given a lysis treatment in the target area for 40 hours to soften the clot.During the procedure, the physician advanced an indigo system aspiration catheter 8 (cat8) into the target area and realized that a sep8 was needed.The cat8 was then removed, flushed, and re-advanced into the target area followed by the sep8.The physician proceeded to make several passes with the cat8 and sep8 before the cat8 became full of clot.The cat8 and sep8 were then removed.While flushing the cat8 and indigo system aspiration tubing (tubing) with a syringe of saline, the nurse noticed that clot was stuck somewhere in the flow switch.The nurse began flushing the flow switch with saline and found that the distal wire tip of the sep8 had broken off during the procedure and had been aspirated into the flow switch.The tip was then removed, and the procedure was completed using a new sep8, the same cat8, and the same tubing.A final phlebography was performed and revealed full recanalization of the target vessels.The physician also observed that there was some old eccentric clot at the walls of the intima, which by nature cannot be removed by the indigo system.Therefore, the patient was given another lysis treatment to break down the remaining clot.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the sep8 core wire and wrapping wire were fractured distal to the bulb.The distal fractured segment was not returned for evaluation.Conclusion: evaluation of the returned sep8 confirmed the atraumatic tip distal to the bulb was fractured.If the sep8 is forcefully manipulated repeatedly through tough clot burden, damage such as this may occur.If the core wire fractures, the wrapping wire may fatigue and fracture if the device continues to be used.The cat8, tubing and the distal fractured segment of the sep8 were not returned for evaluation.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 8
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9311273
• Report Number: 3005168196-2019-02111
• Device Sequence Number: 468416
• Product Code: DXE
• UDI-Device Identifier: 00814548017440
• UDI-Public: 00814548017440
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 10/18/2019
• 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: 04/29/2022
• Device Catalogue Number: SEP8
• Device Lot Number: F89945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 12/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 110
• Date Report Sent to FDA: 01/01/2005