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

Catalog Number	PNS6F125SIMV
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/03/2018
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.
Event or Problem Description
During preparation for a medical procedure, the physician experienced resistance while advancing the neuron select catheter 6f (6f select) through a neuron max 6f 088 long sheath (neuron max) prior to inserting into the patient's body.Therefore, the 6f select was removed.The procedure was completed using a new 6f select and the same neuron max.
Additional Manufacturer Narrative
Results: the 6f select was undamaged.The device was able to pass through the 0.087 inch ring gauge with moderate resistance.Conclusions: evaluation of the returned 6f select revealed an undamaged device.During functional testing the 6f select was able to be advanced through a demonstration catheter without issue.The device was able to pass through the 0.087 inch ring gauge; therefore, it is within specification.The cause of the reported inability of the 6f select to advance through the neuron max was unable to be determined.Evaluation of the neuron max revealed an ovalization on its distal end, and bends along its length.It was stated that the neuron max was successfully used in the procedure; therefore, the damages observed were likely incidental to the reported 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.

• Brand Name: NEURON SELECT CATHETER 6F
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8035445
• Report Number: 3005168196-2018-02185
• Device Sequence Number: 19213879
• Product Code: DQY
• UDI-Device Identifier: 00814548012063
• UDI-Public: 00814548012063
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K083125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018
• 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: 12/08/2019
• Device Catalogue Number: PNS6F125SIMV
• Device Lot Number: F73059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/05/2018
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 03/01/2019
• 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