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

Model Number	PNML6F088904M
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2021
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: 3005168196-2021-01110.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right middle cerebral artery (mca) using a penumbra system ace 60 reperfusion catheter (ace60) and neuron max 6f 088 long sheath (neuron max).During the procedure, the physician was experiencing resistance while advancing the ace60 through the neuron max and into the cavernous sinus segment; therefore, the physician decided to remove the ace60 and neuron max.Subsequently, upon removal, the physician noticed the distal end of the ace60 and neuron max to be kinked.The procedure was completed using a new ace60 and neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned ace60 confirmed kinks and revealed ovalization on its distal shaft.If the device is forcefully advanced against resistance during the procedure, damage such as this may occur.The resistance was likely contributed by the damage neuron max which was used in the procedure.During functional testing, the ace60 was able to be advanced through a demonstration neuron max without an issue.Evaluation of the returned neuron max revealed a kink in its distal shaft.If the device is forcefully mishandled during use, damage such as this may occur.This damage likely contributed to the resistance while advancing the ace60 during the procedure.During functional testing, the returned ace60 and a demonstration ace60 were able to be advanced through the neuron max with resistance due to the neuron max kink.Penumbra catheters 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.This report is associated with mfr report number: 1.3005168196-2021-01110 h3.Other text : placeholder.

• 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: 11852495
• Report Number: 3005168196-2021-01111
• Device Sequence Number: 3724285
• Product Code: DQY
• UDI-Device Identifier: 00814548012162
• UDI-Public: 00814548012162
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021
• 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: 10/22/2022
• Device Model Number: PNML6F088904M
• Device Catalogue Number: PNML6F088904M
• Device Lot Number: H10125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Date Report Sent to FDA: 01/01/2005