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

Catalog Number PND6F0701058M

Device Problems Break (1069); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 05/09/2018

Event Type  malfunction  

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: 3005168196-2018-01110, 3005168196-2018-01111.

Event 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.

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 17.0 and 20.5 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
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7569544
• MDR Text Key: 110087748
• Report Number: 3005168196-2018-01112
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548010052
• UDI-Public: 00814548010052
• Combination Product (y/n): Y
• Reporter Country Code: GR
• PMA/PMN Number: K082290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/11/2018

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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 05/11/2018
• Initial Date FDA Received: 06/05/2018
• Supplement Dates Manufacturer Received: 07/05/2018
• Supplement Dates FDA Received: 07/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1