MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX; DQY

Catalog Number	PNML6F088904M
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2019
Type of Reportable Event	Serious Injury
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 middle cerebral artery (mca) using a neuron max 6f 088 long sheath (neuron max).During the procedure, while advancing the neuron max with a non-penumbra access sheath through the basilar artery, the physician experienced slight resistance and the tip of the neuron max broke off inside of the patient.Therefore, the physician used a stent retriever to successfully remove the broken tip of the neuron max and decided to end the procedure.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The neuron max was kinked approximately 26.0 cm from the hub.The device was ovalized approximately 63.5 ¿ 64.0 cm from the hub and at the distal atraumatic tip.The distal atraumatic tip was fractured approximately 92.5 cm from the hub and was not returned for evaluation.Conclusions: evaluation of the returned neuron max confirmed a fractured distal atraumatic tip.This type of damage typically occurs while retracting the device against resistance.The non-penumbra access sheath and distal fractured segment of the neuron max were not returned for evaluation; therefore, the root cause of the fracture could not be determined.Further evaluation revealed a kink and ovalization.These damages were likely incidental to the reported 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
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8579846
• Report Number: 3005168196-2019-00873
• Device Sequence Number: 1837102
• Product Code: DQY
• UDI-Device Identifier: 00814548012162
• UDI-Public: 00814548012162
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• 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): 04/05/2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/23/2019
• Device Catalogue Number: PNML6F088904M
• Device Lot Number: C09810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Weight: 68
• Date Report Sent to FDA: 01/01/2005