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

Catalog Number	PND6F070956M
Medical Device Problem Codes	Peeled/Delaminated (1454); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the neuron 070 was fractured approximately 95.0 cm from the hub.The distal fractured segment of the neuron 070 was on the packaging mandrel and the marker coil was present.The packaging tape that covers the packaging mandrel was torn.Conclusions: evaluation of the returned neuron 070 revealed that the catheter was fractured.If the distal tip of the device is pushed underneath the packaging tape, resistance will likely be experienced.If the device is subsequently retracted against this resistance, damage such as a fracture may occur.The root cause of the catheter shifting to become stuck under the packaging tape could not be determined.Further evaluation of the returned neuron 070 revealed that the marker coil was present and not peeled off the distal fractured segment of the device.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 hospital staff found that the radio-opaque marker of the neuron 6f 070 delivery catheter (neuron 070) was peeled off upon removal from packaging.Therefore, the neuron 070 was not used in the procedure.The procedure was completed using a new 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: 8279064
• Report Number: 3005168196-2019-00157
• Device Sequence Number: 13828102
• Product Code: DQY
• UDI-Device Identifier: 00814548010076
• UDI-Public: 00814548010076
• Combination Product (Y/N): Y
• Initial Reporter Country: TW
• 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
• Report Date (Section B): 12/28/2018
• 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: 07/09/2021
• Device Catalogue Number: PND6F070956M
• Device Lot Number: F84549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• 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: 12/28/2018
• Initial Report FDA Received Date: 01/25/2019
• 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