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

Model Number	PNML6F088804
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 1.3005168196-2020-00666.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the basilar artery using a penumbra system jet 7 reperfusion catheter (jet7), neuron max 6f 088 long sheath (neuron max), non-penumbra catheter, and non-penumbra stent retriever device.During the procedure, the neuron max was placed in the vertebral artery.Next, the catheter was advanced through the neuron max and into the basilar artery, but the neuron max was kicked out of the vessel; subsequently, the catheter was removed.The physician then advanced a jet7 through the same neuron max, but the same issue occurred.Subsequently, the physician attempted to retract the jet7, but the tip of the jet7 became stuck in the neuron max.Upon pulling on the jet7, the tip broke/ unraveled; therefore, the physician removed the neuron max with the broken jet7 tip.The physician made one more pass using the non-penumbra catheter and stent retriever device via the radial artery but was not able to revascularize.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the returned neuron max was kinked approximately 76.0 cm from the hub.During functional testing, a test mandrel was attempted to insert through the neuron max and resistance was encountered approximately 35.0 cm inside the neuron max.Therefore, the neuron max was cut approximately 36.0 cm from the hub and the distal portion of the fractured jet7 was found stuck inside the neuron max.The fractured portion of the jet7 was removed from the neuron max.Conclusions: evaluation of the returned jet7 confirmed a fracture at its mid-shaft.Further evaluation revealed that the jet7 was stretched before and after the fractured location, and the device was ovalized distal to the stretched location.If the jet7 is forcefully retracted out of a kinked device, damages such as these may occur.Evaluation of the returned neuron max revealed a distal kink.If the neuron max is forcefully manipulated against resistance, damage such as a kink may occur.The root cause of the resistance was unable to be determined.The kink in the neuron max likely contributed to the damages on the returned jet7.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.This report is associated with mfr report number: 1.3005168196-2020-00666.

• 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: 10075424
• Report Number: 3005168196-2020-00667
• Device Sequence Number: 2848211
• Product Code: DQY
• UDI-Device Identifier: 00814548012216
• UDI-Public: 00814548012216
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 05/01/2020
• 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: 09/17/2022
• Device Model Number: PNML6F088804
• Device Catalogue Number: PNML6F088804
• Device Lot Number: H10063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/01/2020
• Supplement Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 06/09/2020
• 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