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

Model Number SEP8-A

Device Problem Break (1069)

Patient Problems Death (1802); Heart Failure (2206)

Event Date 05/29/2020

Event Type  Injury  

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.

Event Description

The patient was undergoing a thrombectomy procedure in the right pulmonary artery using an indigo system separator 8 (sep8), an indigo system aspiration catheter 8 (cat8), a neuron select catheter 6f (6f select), a non-penumbra sheath and a guidewire.During the procedure, the physician placed the sheath in the right pulmonary artery, then advanced the cat8 over the guidewire through the sheath and into the lower lobe of the right lung.Next, the physician removed the guidewire, advanced the sep8 through the cat8 and made two passes with aspiration.The sep8 was then removed and the physician advanced the guidewire and a 6f select through the cat8 into the right upper lung.The physician then removed the guidewire and 6f select, then advanced the sep8 through the cat8.Next, aspiration was initiated.While advancing and retracting the sep8, the physician noticed that the distal tip of the sep8 had broken off.The physician attempted to aspirate the broken distal tip of the sep8 using the cat8, however it was unsuccessful.It was also reported that the physician thought that the broken distal tip of the sep8 was stuck in the clot; therefore, the physician used a new sep8 to attempt to remove the clot and the broken distal tip of the sep8 but was also unsuccessful.Therefore, the sep8 was removed.The physician used a snare device to remove the broken distal tip of the sep8 and then removed the cat8.The procedure ended at this point.It was reported that the patient expired prior to leaving the operating room due to right side heart failure.The patient¿s death was unrelated to the sep8.It was also reported that prior to the thrombectomy procedure, the patient had infusion catheters in both lobes and had started to code throughout the day, becoming unstable.

Manufacturer Narrative

Evaluation of the returned sep8 confirmed that the atraumatic tip distal to the bulb was fractured.If the sep8 is repeatedly manipulated through tough clot burden, damage such as this may occur.If the core wire fractures, the wrapping wire may fatigue and fracture as well.No other devices associated with the complaint were 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
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10174399
• MDR Text Key: 195887015
• Report Number: 3005168196-2020-00797
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548017440
• UDI-Public: 00814548017440
• Combination Product (y/n): Y
• PMA/PMN Number: K161523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2022
• Device Model Number: SEP8-A
• Device Catalogue Number: SEP8
• Device Lot Number: F94722
• 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
• Initial Date Manufacturer Received: 05/29/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 03/15/2021
• Supplement Dates FDA Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR