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

Catalog Number	PNML6F088804M
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2019
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 right internal carotid artery (ica) using a neuron max 6f 088 long sheath (neuron max).During the procedure, while advancing the neuron max across the aortic arch, the physician experienced resistance and the proximal zone became kinked.It was also reported that the surface coating of the neuron max was observed to be peeling.The neuron max was removed, and 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 returned neuron max was kinked at approximately 75.0 cm from the hub.The device was ovalized at approximately 78.0 cm from the hub.The catheter was damaged at approximately 77.0 cm and 83.0 cm from the hub.Conclusions: evaluation of the returned neuron max confirmed a kink.If the neuron max is forcefully manipulated against resistance, the neuron max may become kinked.Further investigation revealed that the catheter was damaged at multiple locations on the distal shaft.These damages may be the reported surface coating peeling by the customer; however, it was determined that the coating was not actually peeling.The root cause of the catheter damage was unable to be determined.The distal ovalization that was observed on the returned neuron max was likely incidental to the complaint.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: 9177199
• Report Number: 3005168196-2019-01909
• Device Sequence Number: 2774608
• Product Code: DQY
• UDI-Device Identifier: 00814548012209
• UDI-Public: 00814548012209
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• 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): 09/13/2019
• 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: 06/19/2020
• Device Catalogue Number: PNML6F088804M
• Device Lot Number: F77764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Date Report Sent to FDA: 01/01/2005