MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 6; DXE

Model Number	SEP6
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2020
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: 3005168196-2020-00916.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right subclavian and axillary vein using an indigo system aspiration catheter 6 (cat6), indigo system separator 6 (sep6) and, a non-penumbra sheath.It was reported that the patient was brought back after a round of infusion and the physician wanted to utilize the existing access and did not want to upsize existing sheath in the right upper arm.It was also noted that the access to the lesion was tortuous.During the procedure, the physician made multiple passes using the cat6 and sep6.While attempting to make another pass, the hospital technician experienced resistance while advancing and retracting the sep6.After some time, the physician noticed that there was no flow in the aspiration tubing; therefore, the cat6 and sep6 were removed as a unit.Upon removal, it was noticed that the cat6 was ovalized around the distal end.The physician then removed the sep6 from the cat6 and noticed that the distal bulb of the sep6 was missing.The cat6 was subsequently flushed and the broken distal bulb of the sep6 was ejected from the cat6.The procedure was completed using a balloon catheter and balloon angioplasty.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the sep6 core wire was fractured approximately 174.5 cm from the proximal end and the sep6 bulb was fracture off the delivery wire.Conclusions: evaluation of the returned cat6 confirmed that the distal shaft of the catheter was ovalized.If the cat6 is forcefully manipulated against resistance during use, damage such as ovalization may occur.The tortuous lesion may have contributed to the reported resistance.Evaluation of the returned sep6 revealed that the bulb was fractured off the delivery wire.If the sep6 is forcefully manipulated against resistance, damage such as this may occur.The root cause of resistance was likely the ovalization in the cat6.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.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.This report is associated with mfr report number: 1.3005168196-2020-00916.

• Brand Name: INDIGO SYSTEM SEPARATOR 6
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10256664
• Report Number: 3005168196-2020-00917
• Device Sequence Number: 2964049
• Product Code: DXE
• UDI-Device Identifier: 00814548016146
• UDI-Public: 00814548016146
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 06/17/2020
• 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: 12/02/2022
• Device Model Number: SEP6
• Device Catalogue Number: SEP6
• Device Lot Number: F94607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 08/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Date Report Sent to FDA: 01/01/2005