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

Catalog Number	SEP5
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2017
Type of Reportable Event	Malfunction
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.This report is associated with mfr report number: 3005168196-2017-02289.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in a popliteal vein using an indigo system cat5 aspiration catheter (cat5) and an indigo system separator 5 (sep5).During the procedure, while using the sep5 within the cat5, the sep5 perforated through the side of the cat5.It was reported that this was a chronic clot, and though the physician felt resistance while using the sep5 within the vessel, there was no resistance while advancing within the cat5.The physician therefore removed the cat5 and sep5, and attempted to use a non-penumbra catheter to remove the thrombus, however was still unsuccessful.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The indigo system separator 5 (sep5) was punctured through the indigo system cat5 aspiration cathete (cat5) approximately 130.0 cm from the hub.The sep5 core wire was fractured approximately 171.5 and 173.5 cm from the proximal end.The bulb was still intact with the core wire.Evaluation of the returned devices revealed that the sep5 core wire was fractured.This type of damage likely occurred due to improper handling during use.If the sep5 is forcefully retracted against resistance, damage such as the core wire may fractured.The retraction against resistance likely contributed the core wire fracturing.Evaluation of the cat5 revealed that the sep5 was punctured through the distal shaft.This type of damage likely occurred after the sep5 core wire fractured and then advanced within the cat5.Attempts to advance the already-fractured sep5 likely caused the puncturing of the distal shaft of the cat5.Penumbra separators and catheters 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.This report is associated with mfr report number: 3005168196-2017-02289.

• Brand Name: INDIGO SYSTEM SEPARATOR 5
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7151723
• Report Number: 3005168196-2017-02288
• Device Sequence Number: 13634010
• Product Code: DXE
• UDI-Device Identifier: 00814548016108
• UDI-Public: 00814548016108
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2017

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: Physician
• Device Expiration Date: 12/21/2019
• Device Catalogue Number: SEP5
• Device Lot Number: F73269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 12/28/2017
• Supplement Report FDA Received Date: 02/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR