MAUDE Adverse Event Report: PENUMBRA, INC. NEURON SELECT CATHETER 5F; DQY

Catalog Number	PNS5F130BER
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/25/2019
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.This report is associated with mfr report number: 3005168196-2019-00551.
Event or Problem Description
During preparation for a medical procedure, the hospital staff was unable to advance two neuron select catheter 5fs (5f select) over a guide wire on the back table; therefore, they were not used in the procedure.It was reported that the 5f selects were kinked at the mid-shaft.The procedure was completed using another 5f select.
Additional Manufacturer Narrative
Results: the 5f select was kinked approximately 1.5 cm from the hub.The device was ovalized from approximately 4.0 - 7.0 cm, 58.5 ¿ 60.5 cm and 83.5 ¿ 84.5 cm from the hub.Resistance was experienced while attempting to advance a 0.040¿ stainless steel mandrel through both devices and the mandrel was unable to advance through either device.Conclusions: evaluation of both returned 5f selects revealed ovalizations throughout each device.If the devices are forcefully gripped or otherwise mishandled during preparation, damage such as ovalizations will likely occur.These damages likely contributed to the reported inability to advance the 5f selects over a guidewire.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.This report is associated with mfr report number: 3005168196-2019-00551.

• Brand Name: NEURON SELECT CATHETER 5F
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8451306
• Report Number: 3005168196-2019-00552
• Device Sequence Number: 240762
• Product Code: DQY
• UDI-Device Identifier: 00814548010212
• UDI-Public: 00814548010212
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K083125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2019
• 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: 08/28/2021
• Device Catalogue Number: PNS5F130BER
• Device Lot Number: F85564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/25/2019
• Supplement Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 05/07/2019
• 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