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

Catalog Number	PNML6F088804
Medical Device Problem Codes	Fracture (1260); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Results: the neuron max 6f 088 long sheath (neuron max) was fractured approximately 3.0 cm from the hub underneath the strain relief.The strain relief was cut near the fractured segment by a penumbra investigator for further evaluation.Conclusion: evaluation of the returned device confirmed that the neuron max was fractured.This type of damage typically occurs due to improper handling during removal from the packaging.If the device is forcefully retracted out of its packaging at extreme angles, damage such as this may occur.The strain relief was cut off by the penumbra investigator for further evaluation of the fractured location near the hub.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
During preparation for a medical procedure, the physician noticed that the neuron max 6f 088 long sheath (neuron max) was fractured around the strain relief upon removal from the packaging.The damaged neuron max was found prior to use and therefore, was not used in the procedure.The procedure was completed using another neuron max.

• 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: 6842615
• Report Number: 3005168196-2017-01507
• Device Sequence Number: 636967
• Product Code: DQY
• UDI-Device Identifier: 00814548012216
• UDI-Public: 00814548012216
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 08/10/2017

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: Physician
• Device Expiration Date: 09/20/2019
• Device Catalogue Number: PNML6F088804
• Device Lot Number: F71666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2017
• Initial Report FDA Received Date: 09/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1