MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX 6F 088 LONG SHEATH; DQY

Catalog Number	PNML6F088804
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the neuron max 6f 088 long sheath (neuron max) was kinked approximately 18.0 and 71.0 cm from the hub.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.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: 3005168196-2018-00083.
Event or Problem Description
During preparation for a medical procedure, the physician experienced resistance while attempting to insert a neuron select catheter 6f (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.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7325673
• Report Number: 3005168196-2018-00501
• Device Sequence Number: 18869875
• Product Code: DQY
• UDI-Device Identifier: 00814548012216
• UDI-Public: 00814548012216
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111380
• 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
• 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 Catalogue Number: PNML6F088804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2017
• Initial 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