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

Catalog Number	PNS5F130BER
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the 5f select was ovalized approximately 9.0 cm, 44.0 cm ¿ 44.5 cm, and 48.5 cm ¿ 51.5 cm from the hub.The 5f select had a bend approximately 22.5 cm from the hub.Significant resistance was encountered at the ovalization 51.5 cm from the hub while attempting to advance the 5f select through a demonstration catheter.Conclusions: evaluation of the returned 5f select revealed an ovalized and bent device.If the device is forcefully gripped during insertion or preparation, damage such as ovalization may occur.The ovalizations likely contributed to the inability to advance the 5f select through the hub of a neuron 070.Further evaluation revealed a bend in the device.Based on the return condition, the bend is likely incidental to the complaint and may have occurred during packaging for return to penumbra.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.
Event or Problem Description
The patient was undergoing a medical procedure using a neuron select catheter 5f (5f select).During the procedure, the physician was unable to advance the 5f select through the hub of a neuron 6f 070 delivery catheter (neuron 070); therefore, the 5f select was removed.The procedure was completed using a new 5f select and the same neuron 070.There was no report of an adverse effect to the patient.

• Brand Name: NEURON SELECT CATHETER 5F
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8059525
• Report Number: 3005168196-2018-02213
• Device Sequence Number: 2745426
• Product Code: DQY
• UDI-Device Identifier: 00814548010212
• UDI-Public: 00814548010212
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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
• Report Date (Section B): 10/15/2018
• 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: 08/22/2021
• Device Catalogue Number: PNS5F130BER
• Device Lot Number: F85437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Date Report Sent to FDA: 01/01/2005