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	02/24/2019
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 procedure in the anterior artery using an indigo system separator 6 (sep6) and an indigo system aspiration catheter 6 (cat6).It was reported that there was a stenosis at the target location.During the procedure, the physician engaged the cat6 through the stenosis with force, then experienced resistance while advancing the sep6 through the cat6.While advancing the sep6 in and out of the cat6, the physician noticed under fluoroscopy that the wire distal to the bulb of the sep6 was missing; therefore, the sep6 was removed.It was reported that the broken wire of the sep6 was found on the sterilized table, and it is unknown how it ended up on the sterilized table.It was also reported the cat6 kinked while advancing through the stenosis.The procedure was completed using a new sep6 and same cat6.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the sep6 was kinked approximately 172.5 ¿ 174.0 cm from the proximal end and the separator bulb was not present.Conclusions: evaluation of the returned sep6 revealed kinks on the distal shaft and the bulb was missing.If the sep6 is repeatedly manipulated against resistance, damage such as these may occur.Evaluation of the returned cat6 revealed kinks and ovalizations on the mid-shaft.If the device is forcefully advanced against resistance, damage such as these may occur.During functional testing, resistance was experienced while attempting to advance a stainless-steel test mandrel through the cat6 due to the kink and the mandrel could not advance any further.The kink likely contributed to the resistance while advancing the sep6 during the procedure.Penumbra separators and catheters 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.This report is associated with mfr report number: 1.3005168196-2020-01107 h3 other text : placeholder.

• Brand Name: INDIGO SYSTEM SEPARATOR 6
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9892273
• Report Number: 3005168196-2020-00463
• Device Sequence Number: 2101696
• Product Code: DXE
• UDI-Device Identifier: 00814548016146
• UDI-Public: 00814548016146
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K160533
• 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): 03/06/2020
• 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: 12/05/2021
• Device Model Number: SEP6
• Device Catalogue Number: SEP6
• Device Lot Number: F87358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005