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

Catalog Number	PND6F0701058M
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/09/2018
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.This report is associated with mfr report numbers: 3005168196-2018-01111, 3005168196-2018-01112.
Event or Problem Description
During preparation for a coil embolization procedure, the interventional radiologist found that the three neuron 6f 070 delivery catheters (neuron 070s) were broken at multiple points upon removal from the packaging.The damages to the neuron 070s were found prior to use.Therefore, the neuron 070s were not used in the procedure.The procedure was completed using a new neuron 070.
Additional Manufacturer Narrative
Results: the neuron 070 product display box was damaged.The packaging card was creased.The neuron 070 was ovalized approximately 68.5 cm from the hub.The device was kinked approximately 37.0, 39.0, 41.0, 58.0 and 62.0 cm from the hub.The complaint did not involve device functionality, therefore, functional analysis was not performed.Conclusions: evaluation of the returned neuron 070s revealed ovalized devices.The product display boxes and packaging cards were creased and damaged.This damage likely occurred due to improper handling during transit from penumbra to the hospital.Further evaluation revealed kinks on the devices.If the device is forcibly manipulated at extreme angles from the packaging tube, damage such as a kink may occur.Penumbra catheters and product display boxes 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.

• Brand Name: NEURON DELIVERY CATHETER 070
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7569530
• Report Number: 3005168196-2018-01110
• Device Sequence Number: 16187650
• Product Code: DQY
• UDI-Device Identifier: 00814548010052
• UDI-Public: 00814548010052
• Combination Product (Y/N): Y
• Initial Reporter Country: GR
• 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): 05/11/2018
• 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: Physician
• Device Expiration Date: 09/14/2020
• Device Catalogue Number: PND6F0701058M
• Device Lot Number: F79538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/11/2018
• Supplement Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 07/31/2018
• 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