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

Catalog Number	PNS6F125BER
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance (2578)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/06/2017
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 attempting to insert a neuron 6f select catheter (6f select) into a neuron max 6f 088 long sheath (neuron max) on the back table; therefore, it was removed.It was reported that the 6f select did not fit into the neuron max.It was also reported that the physician also had difficulty advancing the neuron max through an 8f sheath.The procedure was completed using a new 6f select, the same neuron max and same 8f sheath.
Additional Manufacturer Narrative
There was no visible damage to the returned neuron select catheter 6f (6f select).However, while attempting to insert a 0.040¿ stainless steel mandrel into the hub 6f select to measure the outer diameter (od) using a ring gauge.The stainless steel mandrel could only be advanced about 5.0 cm into the hub before resistance was met and the mandrel could not be advanced any further.Then the mandrel was attempted to be advanced through the distal tip of the 6f select to attempt to push whatever substance out of the lumen of the 6f select.However, the substance inside the 6f select was unable to be pushed out and the mandrel got stuck inside the 6f select.The distal tip of the 6f select was damaged by the penumbra investigator in an attempt to remove the stainless steel mandrel and the outer diameter of the 6f select could not be measured using a ring gauge.Conclusions: evaluation of the returned devices revealed that the 6f select has some unknown substance inside the lumen.While attempting to advance a stainless steel mandrel through the hub of the 6f select, the mandrel was only able to be advanced approximately 5.0 cm.The mandrel was then attempted to be advanced through the distal tip of the returned 6f select; however, the stainless steel mandrel got stuck inside the 6f select.The distal tip of the 6f select was damaged by the penumbra investigator while attempting to remove the stuck stainless steel mandrel and the od of the 6f select could not be measured.The 6f select could not be functionally tested for the reported issue.Evaluation of the returned neuron max revealed that the sheath was kinked.This type of damage was likely incidental and may have occurred while packaging the device for return to penumbra.The neuron max could not be functionally tested for the reported issue.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.This report is associated with mfr report number: 3005168196-2018-00501.

• Brand Name: NEURON 6F SELECT CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7175896
• Report Number: 3005168196-2018-00083
• Device Sequence Number: 1863978
• Product Code: DQY
• UDI-Device Identifier: 00814548012094
• UDI-Public: 00814548012094
• Combination Product (Y/N): N
• 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): 12/10/2017

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: Physician
• Device Expiration Date: 06/25/2020
• Device Catalogue Number: PNS6F125BER
• Device Lot Number: F77872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Initial Date Received by Manufacturer: 12/10/2017
• Supplement Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1