MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM SEPARATOR 3D; NRY

Catalog Number PSS3D

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the left m1 segment of the middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68), a penumbra system separator 3d (sep3d), a neuron max 6f 088 long sheath (neuron max) and a non-penumbra microcatheter.It was noted that the patient anatomy was tortuous.During the procedure, the physician advanced the neuron max, ace68, microcatheter and sep3d into the patient.While performing the first pass using the solumbra technique, the sep3d became stuck in the left m1 segment of the mca.Therefore, the physician removed the microcatheter and attempted to retract the sep3d into the ace68.However, while retracting the sep3d, the delivery wire of the sep3d broke off in the aortic arch, leaving the sep3d in m1 segment of the mca.The physician decided to terminate the procedure at this point.The patient remains with severe left-hemisphere stroke, hemiplegia, and aphasia.

Manufacturer Narrative

Evaluation of the returned sep3d confirmed that the delivery wire was fractured and revealed that the wrapping wire was unraveled.If the device is forcefully retracted against resistance during the procedure, damage such as this may occur.The tortuous patient anatomy may have contributed to resistance.The distal tip of the fractured sep3d was not returned for evaluation.Further evaluation of the device revealed kinks in the delivery wire.This damage was incidental to the complaint.Penumbra devices 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: PENUMBRA SYSTEM SEPARATOR 3D
• Type of Device: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12256918
• MDR Text Key: 264515040
• Report Number: 3005168196-2021-01706
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): Y
• PMA/PMN Number: K162901
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2023
• Device Catalogue Number: PSS3D
• Device Lot Number: C05093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• 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: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR