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

Model Number SEP6

Device Problems Failure to Advance (2524); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2020-00748.

Event Description

The patient was undergoing a thrombectomy procedure using an indigo system aspiration catheter 6 (cat6), an indigo system separator 6 (sep6) and a non-penumbra sheath.During the procedure, the physician completed two passes in the target location using the cat6, sep6 and sheath.During the third pass, the physician advanced the cat6 over the guidewire, then removed the guidewire.Next, the physician attempted to advance the sep6 through the cat6; however, the sep6 became stuck and would not advance out of the distal tip of the cat6.Therefore, the physician decided to remove the cat6 and sep6.Upon removal, it was noticed that the cat6 distal tip was stretched and the distal end of the sep6 was bent.The procedure was completed using a balloon angioplasty.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the sep6 was kinked approximately 172.5 cm from the proximal end.Conclusions: evaluation of the returned cat6 confirmed that the catheter was stretched on the distal shaft.The root cause of this damage could not be determined.However, if the cat6 is forcefully manipulated against resistance, damage such as stretching may occur.Further evaluation of the returned cat6 revealed that the catheter was ovalized.This damage was likely incidental to the reported complaint.Evaluation of the returned sep6 confirmed that the device was kinked.If the sep6 is forcefully advanced against resistance, damage such as a kink may occur.The ovalization in the returned cat6 likely contributed to the resistance during the procedure.During functional testing, the sep6 was advanced through a demonstration cat6 without an issue.Evaluation of the returned tubing revealed no visible damage.There were no allegations against this device.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: 3005168196-2020-00748 h3 other text : placeholder.

• Brand Name: INDIGO SYSTEM SEPARATOR 6
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10141557
• MDR Text Key: 194764831
• Report Number: 3005168196-2020-00749
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016146
• UDI-Public: 00814548016146
• Combination Product (y/n): Y
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2022
• Device Model Number: SEP6
• Device Catalogue Number: SEP6
• Device Lot Number: F93883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR