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

Catalog Number	PNML6F088804M
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 found that the tip of the neuron max could not be removed from the mandrel.The neuron max was then set aside and was not used in the procedure.The procedure was completed using another neuron max.
Additional Manufacturer Narrative
Results: the returned neuron max was damaged at its distal tip.Conclusions: evaluation of the returned neuron max revealed a damaged distal tip.If the packaging mandrel becomes loose from the packaging card while retracting the device from its packaging tube, the distal tip of the catheter may become pinned between the packaging mandrel and the packaging tube.If the catheter is subsequently retracted from the packaging tube while pinned, its distal tip may become damaged.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: 8364562
• Report Number: 3005168196-2019-00342
• Device Sequence Number: 1914716
• Product Code: DQY
• UDI-Device Identifier: 00814548012209
• UDI-Public: 00814548012209
• Combination Product (Y/N): Y
• Initial Reporter Country: CI
• PMA/510(K) Number: K111380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019
• 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: 01/30/2021
• Device Catalogue Number: PNML6F088804M
• Device Lot Number: F81681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 05/29/2019
• 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