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

Catalog Number	PNML6F088904
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 numbers: 3005168196-2019-00324; 3005168196-2019-00326.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left internal carotid artery (ica) terminus using a neuron max 6f 088 long sheath (neuron max) and a penumbra system jet7 kit.During the procedure, while attempting to advance two neuron maxs with a non-penumbra catheter through a difficult turn from the aortic arch to the left common carotid artery (lcc), the neuron maxs bent and snapped around their distal ends; therefore, they were removed.The physician was then able to advance a third neuron max to the target vessel using another catheter.Next, the physician completed four passes using a penumbra system jet 7 reperfusion catheter (jet7) and a penumbra system 3d revascularization device (psr3d).However, upon removal of the jet7 after a tough fourth pass in the m1 segment of the middle cerebral artery (mca), the physician noticed that the jet7 was ¿accordioned¿ and had collapsed on itself.The procedure was then completed using a penumbra system ace 68 reperfusion catheter (ace68) and a non-penumbra stent retriever device.There was no noted damage or alleged deficiency with the psr3d.Additionally, there was no report of an adverse effect to the patient.

• 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: 8363428
• Report Number: 3005168196-2019-00325
• Device Sequence Number: 2035598
• Product Code: DQY
• UDI-Device Identifier: 00814548012179
• UDI-Public: 00814548012179
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/23/2019
• 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: 03/29/2020
• Device Catalogue Number: PNML6F088904
• Device Lot Number: F75312
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 02/22/2019
• 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