MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 4MAX SEPARATOR; NRY

Catalog Number	PSF041
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the green marker on the proximal end of the penumbra system 4max separator (sep4) was compressed in the proximal direction.During functional testing, the sep4 was successfully advanced through a demonstration penumbra system 4max reperfusion catheter.The torque device accessory was loosened, but could not be removed pass the compressed green marker on the proximal end of the sep4.The stuck torque device prevented the introducer from being removed.Conclusions: evaluation of the returned sep4 revealed that the green marker on the proximal end of the sep4 was compressed in a proximal direction.This compression prevented the torque device from being removed from the sep4, and consequently prevented the introducer from being removed off the proximal end of the sep4.The green marker is a polymer on the most proximal end of the sep4 that is used for identification purposes only, and does not interact with or on the patient anatomy.The torque device is intended to be used at a position distal to the green marker.If the torque device is tightened and shifted over the green marker, the marker may become compressed or otherwise damaged.This will subsequently cause difficulty removing the torque device from the sep4.The second sep4 mentioned in the complaint was not returned for evaluation.Penumbra separators are 100% visually inspected during in-process inspection.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: 3005168196-2016-00798.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left middle cerebral artery (mca) for a cerebral infarction using a penumbra system 4max separator (sep4).During the procedure, the physician first used another manufacturer's thrombectomy device and then switched to the penumbra devices.The sep4 was inserted into a penumbra system 4max reperfusion catheter (4max) and then a torque device was attached to the sep4.However, upon attempting to change the position of the torque device, the physician noticed that it was stuck and unable to be removed from the sep4.Therefore, the physician removed the sep4 and opened a new sep4 and torque device for the procedure.However, the new torque device also became stuck and unable to be removed from the sep4.Therefore, the sep4 was removed and the procedure was completed using the first thrombectomy device from the other manufacturer.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM 4MAX SEPARATOR
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5724749
• Report Number: 3005168196-2016-00797
• Device Sequence Number: 647235
• Product Code: NRY
• UDI-Device Identifier: 00814548010427
• UDI-Public: 00814548010427
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/16/2016

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: Physician
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: PSF041
• Device Lot Number: F67100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2016
• Initial Report FDA Received Date: 06/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1