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

Catalog Number	3MAXS
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 3005168196-2018-00598.The device was not returned.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using penumbra system 3max reperfusion catheter (3maxc) and a penumbra system 3max separator (3maxs).During the procedure, the physician placed a non-penumbra shuttle guiding sheath in the internal carotid artery (ica).The physician then advanced the 3maxc into a penumbra system ace 68 reperfusion catheter (ace68) outside the patient¿s body.After advancing a non-penumbra guidewire into the patient¿s body through the 3maxc, it was confirmed that the torque was not transmitted well with the guidewire.Therefore, the physician switched to a new guidewire; however, the same issue was observed.It was also reported that the 3maxs would not advance through the 3maxc; therefore, the 3maxs and 3maxc were removed.The procedure was completed using a new 3maxc, the same guidewire and ace68.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This report is associated with mfr report number: 3005168196-2018-00596.

• Brand Name: PENUMBRA SYSTEM 3MAX SEPARATOR
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7353425
• Report Number: 3005168196-2018-00598
• Device Sequence Number: 581073
• Product Code: NRY
• UDI-Device Identifier: 00814548012483
• UDI-Public: 00814548012483
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2018
• 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: Physician
• Device Expiration Date: 07/02/2020
• Device Catalogue Number: 3MAXS
• Device Lot Number: F78006
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 11/12/2018
• 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