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

Catalog Number	PND6F0701058
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/01/2018
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 number: 3005168196-2018-02312.
Event or Problem Description
During preparation for a medical procedure, the hospital staff opened a neuron 6f 070 delivery catheter (neuron 070) and found the distal end to be kinked.The hospital staff then opened a second neuron 070 and noticed the same type of damage to the distal end.The damage to both neuron 070 was found prior to use and therefore, it was not used in the procedure.
Additional Manufacturer Narrative
Results: the neuron 070 had a kink approximately 102.0 cm from the hub.The catheter had ovalizations along its distal shaft approximately from 104.0 cm to 111.0 cm from the hub.Conclusions: evaluation of the returned devices revealed that the catheters were ovalized along their distal length.If the catheters are forcefully mishandled during preparation, damages such as this may occur.Further investigation revealed kinks on the returned catheters.These kinks were likely incidental to the reported complaint and may have occurred during packaging for return.Penumbra catheters are 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: 8098024
• Report Number: 3005168196-2018-02313
• Device Sequence Number: 2178966
• Product Code: DQY
• UDI-Device Identifier: 00814548010045
• UDI-Public: 00814548010045
• Combination Product (Y/N): Y
• Initial Reporter Country: SP
• 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): 10/25/2018
• 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: 09/28/2020
• Device Catalogue Number: PND6F0701058
• Device Lot Number: F79770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 11/21/2018
• Supplement Report FDA Received Date: 02/19/2019
• 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