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

Model Number	PNML6F0881004M
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/06/2020
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.
Event or Problem Description
The patient was undergoing a medical procedure using a neuron max 6f 088 long sheath (neuron max).During the procedure, while advancing the neuron max into the patient, the neuron max kinked; therefore, it was removed.The procedure was completed using a new neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the neuron max was kinked approximately 94.5 cm from the hub.Conclusions: evaluation of the returned neuron max confirmed that the catheter was kinked.If the dilator is not properly attached to the neuron max, and subsequently, the neuron max is forcefully advanced against resistance or otherwise mishandled during insertion, damage such as a kink may occur.During the functional test, resistance was encountered while advancing a stainless-steel mandrel through the returned neuron max due to the kink, and the mandrel could not be advanced any further.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.

• 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: 10172274
• Report Number: 3005168196-2020-00787
• Device Sequence Number: 2925087
• Product Code: DQY
• UDI-Device Identifier: 00814548012285
• UDI-Public: 00814548012285
• Combination Product (Y/N): Y
• Initial Reporter Country: DA
• 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
• Report Date (Section B): 05/28/2020
• 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: 05/08/2022
• Device Model Number: PNML6F0881004M
• Device Catalogue Number: PNML6F0881004M
• Device Lot Number: F90154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 08/22/2020
• 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