MAUDE Adverse Event Report: PENUMBRA, INC. NEURON 6F 070 DELIVERY CATHETER; DQY

Catalog Number	PND6F0701058
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the neuron 6f 070 delivery catheter (neuron 070) was fractured approximately 93.0 cm from the hub and ovalized in multiple locations.Conclusions: evaluation of the returned device revealed that the neuron 070 was fractured.This type of damage typically occurs due to improper handling during removal from the packaging.If the device is forcefully retracted from its packaging tube at extreme angles, damage such as this may occur.Further evaluation of the returned device revealed that the neuron max was ovalized in multiple locations through it length.This type of damage likely occurred due to forceful handling during preparation.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 scrub technologist removed the neuron 6f 070 delivery catheter (neuron 070) from its packaging.Upon flushing the neuron 070, the technologist noticed that the neuron 070 was broken.The damaged neuron 070 was found prior to use in the patient and therefore, was not used in the procedure.The procedure was completed using another neuron 070.

• Brand Name: NEURON 6F 070 DELIVERY CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7123978
• Report Number: 3005168196-2017-02233
• Device Sequence Number: 1080063
• Product Code: DQY
• UDI-Device Identifier: 00814548010045
• UDI-Public: 00814548010045
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K082290
• 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): 11/21/2017

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: Other Health Care Professional
• Device Expiration Date: 08/08/2020
• Device Catalogue Number: PND6F0701058
• Device Lot Number: F78586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 12/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1