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

Catalog Number	PND6F0701058M
Medical Device Problem Codes	Stretched (1601); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/15/2019
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 using a neuron 6f 070 delivery catheter (neuron 070), the tip of the neuron 070 became stretched upon removal from the packaging.The neuron 070 was therefore not used in the procedure.The procedure was completed using another neuron 070.
Additional Manufacturer Narrative
Results: the neuron 070 was fractured approximately 105.5 cm from the hub.The neuron 070 was ovalized approximately 9.0 and 9.5 cm from the hub.The fractured distal tip of the neuron 070 was on its packaging mandrel.Conclusions: evaluation of the returned neuron 070 revealed that the catheter was stretched and fractured.If the distal tip of the catheter was pinned underneath the packaging tape or pinched prior to removal of the device from its packaging, resistance may be encountered.If the device is forcefully retracted against resistance, damage such as stretching may occur.Subsequently, if a stretched device is further manipulated, damage such as a fracture may occur.Further evaluation revealed ovalizations on the proximal end.These ovalizations were likely incidental to the reported complaint.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.

• 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: 8544820
• Report Number: 3005168196-2019-00775
• Device Sequence Number: 373905
• Product Code: DQY
• UDI-Device Identifier: 00814548010052
• UDI-Public: 00814548010052
• Combination Product (Y/N): Y
• Initial Reporter Country: CS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2019
• 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: 01/09/2021
• Device Catalogue Number: PND6F0701058M
• Device Lot Number: F81363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 07/24/2019
• 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