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

Catalog Number	PNML6F088804
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the distal tip of the neuron max 6f 088 long sheath (neuron max) was ovalized.The neuron max and dilator were kinked in multiple locations.Conclusions: evaluation of the returned device confirmed the distal tip was ovalized.This damage may have occurred due to forceful gripping or other forceful handling of the neuron max during insertion into patient anatomy.Further evaluation revealed the neuron max and dilator were kinked.This damage was likely incidental and likely occurred during packaging for return to penumbra.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.
Event or Problem Description
The patient was undergoing a medical procedure using a neuron max 6f 088 long sheath (neuron max).During the procedure, the hospital staff noticed upon advancing into the groin of the patient that the tip of the neuron max was ovalized.The neuron max was therefore removed, and the procedure was completed using a new neuron max.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: 7299105
• Report Number: 3005168196-2018-00420
• Device Sequence Number: 11291836
• Product Code: DQY
• UDI-Device Identifier: 00814548012216
• UDI-Public: 00814548012216
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/01/2018

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: 04/16/2020
• Device Catalogue Number: PNML6F088804
• Device Lot Number: F75705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR