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

Catalog Number	PNML6F088904
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the neuron max 6f 088 long sheath (neuron max) was kinked approximately 1.5 cm from the hub underneath the id band.Conclusions: evaluation of the returned neuron max revealed a kink in the catheter.If the neuron max is forcefully manipulated at an extreme angle during use, damage such as a kink may occur.This kink likely prevented the jet7 and velocity from going through the neuron max during the procedure.During the functional test, resistance was encountered while attempting to advance a demonstration jet7 through the returned neuron max and the jet7 could not be advanced through the kink on the neuron max.The jet7, velocity, non-penumbra select catheter, non-penumbra glide wire and, non-penumbra guidewire identified in the complaint was not returned for evaluation.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right m1 segment of the middle cerebral artery (mca) using a neuron max 6f 088 long sheath (neuron max).It was noted that the patient¿s anatomy was tortuous.During the procedure, a 8fr non-penumbra sheath was utilized for a rapid primary access.Next, the physician experienced resistance while advancing the neuron max over a 5fr non-penumbra select catheter and a glidewire into the high cervical segment of the internal carotid artery (ica).The physician then inserted the penumbra system jet 7 reperfusion catheter (jet7), a velocity delivery microcatheter (velocity) and, a guidewire as a system into the neuron max; however, it would only advance approximately three to four inches.It was also reported that the physician continued to advance the neuron max against resistance; consequently, the neuron max became kinked proximally close to the hub.Therefore, a dilator was used to replace the neuron max over the exchange wire.The procedure was completed using a new neuron max with the same jet7, velocity and, guidewire resulting in a thrombolysis in cerebral infarction (tici) 3.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: 9271869
• Report Number: 3005168196-2019-02026
• Device Sequence Number: 145572
• Product Code: DQY
• UDI-Device Identifier: 00814548012179
• UDI-Public: 00814548012179
• 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
• Report Date (Section B): 10/06/2019
• 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: 05/14/2021
• Device Catalogue Number: PNML6F088904
• Device Lot Number: F83417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• 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: 10/06/2019
• Initial Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Date Report Sent to FDA: 01/01/2005