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

Model Number	PNML6F088804M
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2020
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) and a non-penumbra intracranial support catheter.During the procedure, the physician experienced resistance while advancing the intracranial support catheter over the guidewire through the neuron max; therefore, the neuron max was removed.Upon removal of the neuron max, it was noticed that the neuron max was ovalized.The procedure was completed using a new neuron max and the same intracranial support catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the neuron max was ovalized from approximately 75.0 ¿ 82.5 cm from the hub.Conclusions: evaluation of the returned neuron max revealed an ovalization on the distal shaft.If the device is forcefully gripped or pinched during use, damage such as an ovalization may occur.During functional testing, the returned non-penumbra catheter could not be advanced through the returned neuron max due to the ovalization.The non-penumbra catheter was therefore removed from the neuron max, and then advanced through a demonstration neuron max without an issue.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.

• 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: 9740842
• Report Number: 3005168196-2020-00240
• Device Sequence Number: 13644474
• Product Code: DQY
• UDI-Device Identifier: 00814548012209
• UDI-Public: 00814548012209
• Combination Product (Y/N): Y
• Initial Reporter Country: SN
• 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): 01/31/2020
• 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: 08/05/2022
• Device Model Number: PNML6F088804M
• Device Catalogue Number: PNML6F088804M
• Device Lot Number: H10021
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 04/24/2020
• 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