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

Catalog Number	PND6F0701058M
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	08/15/2018
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, the physician felt resistance when removing the neuron 6f 070 delivery catheter (neuron 070) from the packaging mandrel.The tip of the neuron 070 was found stuck to the mandrel and, therefore, the neuron 070 was not used in the procedure.The procedure was completed using a new neuron 070.
Additional Manufacturer Narrative
Results: the packaging mandrel was loose from the packaging tape and the packaging tape was torn.The neuron 070 was still seated on the packaging mandrel.The neuron 070 catheter was able to slide approximately 2.0 cm distal on the packaging mandrel.The neuron 070 was attempted to be retracted from the packaging mandrel and was unable to be removed from its packaging.Conclusions: evaluation of the returned neuron 070 revealed a device unable to be removed from its packaging mandrel.If the device is slid underneath the packaging tape, the device may be adhered onto the packaging mandrel by the packaging tape and subsequently unable to be retracted from the packaging.This likely contributed to the reported experienced resistance when removing the device.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 DELIVERY CATHETER 070
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7981385
• Report Number: 3005168196-2018-02044
• Device Sequence Number: 1578963
• Product Code: DQY
• UDI-Device Identifier: 00814548010052
• UDI-Public: 00814548010052
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K082290
• 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): 09/21/2018
• 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: 06/07/2019
• Device Catalogue Number: PND6F0701058M
• Device Lot Number: F70022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 02/19/2019
• 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