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

Model Number	PNML6F088904M
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2020
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 number: 3005168196-2020-00849.
Event or Problem Description
On (b)(6) 2020, the patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a neuron max 6f 088 long sheath (neuron max), a neuron select catheter 6f, a penumbra system jetd reperfusion catheter (jetd) and a velocity delivery microcatheter (velocity) and a non-penumbra sheath.During the procedure, the physician placed a sheath with the neuron max and 6f select.Then, the physician advanced the jetd over the velocity through the neuron max and experienced resistance at the distal end of the neuron max; therefore, the entire system was removed.After the removal of the entire system, it was noticed that the neuron max was kinked.The procedure was completed using a new penumbra system ace 60 reperfusion catheter (ace60), a new neuron max, and the same velocity.There was no report of an adverse effect to the patient.On (b)(6) 2020, a post-procedure imaging was performed, and it indicated that there was an unknown item remaining in the patient¿s brain.It was reported that the item had broken off and migrated into the open m2 segment of the mca due to the other branch of m2 being occluded.No intervention was performed.Patient¿s status unknown.

• 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: 10215426
• Report Number: 3005168196-2020-00848
• Device Sequence Number: 2565215
• Product Code: DQY
• UDI-Device Identifier: 00814548012162
• UDI-Public: 00814548012162
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 06/04/2020
• 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: 11/11/2022
• Device Model Number: PNML6F088904M
• Device Catalogue Number: PNML6F088904M
• Device Lot Number: H10147
• 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: 06/04/2020
• Initial Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Date Report Sent to FDA: 01/01/2005