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

Catalog Number	PNML6F088804M
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the distal atraumatic tip was fractured approximately 82.5 cm from the hub.The tape was detach on the packaging card and the packing mandrel was loose inside the sterile pouch with the fractured atraumatic tip on it.The complaint did not involve device functionality, therefore, no functional testing was performed.Conclusions: evaluation of the returned neuron max revealed a fractured atraumatic tip.The packaging mandrel was returned inside the opened sterile pouch detached from the packaging card.If the mandrel is unsecured from the packaging card during retraction of the neuron max, it may pull into the packaging tube.This may cause the distal atraumatic tip of the neuron max to become pinned between the packaging mandrel and the packaging tube.If the neuron max is retracted against this resistance, the distal tip will likely become fractured.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
During preparation for a medical procedure, the physician noticed the distal tip of the neuron max 6f 088 long sheath (neuron max) was broken upon removal from the packaging.The damage to the neuron max was found prior to use and, therefore, the neuron max was not used in the procedure.The procedure was completed using a new 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: 7916615
• Report Number: 3005168196-2018-01887
• Device Sequence Number: 13667112
• Product Code: DQY
• UDI-Device Identifier: 00814548012209
• UDI-Public: 00814548012209
• Combination Product (Y/N): Y
• 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): 08/28/2018
• 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: 11/01/2020
• Device Catalogue Number: PNML6F088804M
• Device Lot Number: F80321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• 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: 08/28/2018
• Initial Report FDA Received Date: 09/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005