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

Model Number	PNML6F088904
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2017
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m2 segment of the middle cerebral artery (mca) using a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician was unable to re-advance the non-penumbra catheter into the neuron max.The neuron max was therefore removed and was no longer used in the procedure.The procedure was completed using another neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the neuron max was kinked approximately 1.5 cm from the hub.Conclusions: evaluation of the returned neuron max revealed a kink near the hub.If the device is forcefully mishandled or otherwise manipulated at extreme angles, damage such as a kink may occur.Further evaluation of the returned neuron max revealed a fracture underneath the id band.This damage typically occurs if a kinked device is further manipulated and the kink worsens to a fracture.These damages likely prevented the non-penumbra catheter from being re-advanced through the neuron max during the procedure.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.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being updated on this follow-up # 01 mfr report: 3005168196-2019-01559.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #03 mfr report: 3005168196-2019-01559: section e.Box 4.Initial reporter also sent report to fda.

• 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: 8881409
• Report Number: 3005168196-2019-01559
• Device Sequence Number: 13525684
• Product Code: DQY
• UDI-Device Identifier: 00814548012179
• UDI-Public: 00814548012179
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/01/2019
• 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: 06/26/2021
• Device Model Number: PNML6F088904
• Device Catalogue Number: PNML6F088904
• Device Lot Number: F84330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 10/01/2019; 10/01/2019; 01/14/2005
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 10/24/2019; 10/24/2019; 09/16/2020
• 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