MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX 6F 088 LONG SHEATH; DQY

Model Number	PNML6F088804
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional 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: 3005168196-2020-01570.
Event or Problem Description
The patient was undergoing an embolization procedure by flow diversion in the internal carotid artery (ica) using a neuron 6f 070 delivery catheter (neuron 070) and a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician experienced resistance while attempting to advance a neuron 070 through the neuron max and subsequently, the neuron 070 was unable to advance through the neuron max.Therefore, the neuron max was removed.The physician then attempted to insert the same neuron 070 into a new neuron max; however, the same issue occurred.Therefore, the neuron 070 was removed.The procedure was completed using a new neuron 070 and the same second neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned neuron max revealed a functional device.During the functional test, the returned neuron 070 could not be advance through the neuron max due to the distal ovalization.A stainless-steel mandrel was advanced through the returned neuron max without an issue.Evaluation of the returned neuron 070 revealed ovalization on the distal shaft.If the peel-able sheath (supplied by penumbra) is not used to protect the distal shaft during insertion, damage such as ovalizations may occur.Further evaluation revealed a kink underneath the strain relief.This damage was likely incidental to the reported complaint.Penumbra catheters 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: 3005168196-2020-01570.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10586364
• Report Number: 3005168196-2020-01569
• Device Sequence Number: 13764555
• Product Code: DQY
• UDI-Device Identifier: 00814548012216
• UDI-Public: 00814548012216
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K111380
• 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): 08/31/2020
• 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: Health Professional
• Device Expiration Date: 11/06/2022
• Device Model Number: PNML6F088804
• Device Catalogue Number: PNML6F088804
• Device Lot Number: H10143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Date Report Sent to FDA: 01/01/2005