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

Catalog Number	PNML6F088904M
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
During preparation for a medical procedure using a neuron max 6f 088 long sheath (neuron max), the physician noted that the green dilator looked significantly different and also appeared to have a piece broken off.The issue with the neuron max was found prior to use and therefore it was not used in the procedure.The procedure was completed using another neuron max.
Additional Manufacturer Narrative
Results: the returned neuron max was undamaged.The dilator was fractured at its distal tip.The total length of the dilator was measured approximately 109.0 cm from the hub.Conclusions: evaluation of the returned neuron max and dilator revealed an undamaged neuron max and a fractured dilator.The dilator was fractured at its distal tip and the broken piece of the dilator tip was not returned.The root cause of the reported broken dilator could not be determined.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 6F 088 LONG SHEATH
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8758342
• Report Number: 3005168196-2019-01299
• Device Sequence Number: 1489544
• Product Code: DQY
• UDI-Device Identifier: 00814548012162
• UDI-Public: 00814548012162
• 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,Followup
• Report Date (Section B): 06/05/2019
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2021
• Device Catalogue Number: PNML6F088904M
• Device Lot Number: F86979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 08/15/2019
• 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