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

Catalog Number	PND6F070956M
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the neuron 070 was kinked approximately 8.0 cm from the hub.The neuron 070 was ovalized approximately 51.0, and 95.0 through 99.0 cm from the hub.Conclusions: evaluation of the returned neuron 070 revealed that the tip was ovalized.This type of damage typically occurs if the device is forcefully retracted out of its packaging tube at an extreme angle.Further evaluation of the neuron 070 revealed that the catheter shaft was kinked.This kink was likely incidental and may have occurred due to packaging of the device during the return to penumbra.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 tip of the neuron 6f 070 delivery catheter (neuron 070) was ruined upon removal from the packaging.The damage to the neuron 070 was found prior to use.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: 7741386
• Report Number: 3005168196-2018-01500
• Device Sequence Number: 1618524
• Product Code: DQY
• UDI-Device Identifier: 00814548010076
• UDI-Public: 00814548010076
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K082290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2018
• 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: 02/22/2021
• Device Catalogue Number: PND6F070956M
• Device Lot Number: F82054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 08/24/2018
• 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