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

Catalog Number	PNML6F088804
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a medical procedure in the right internal carotid artery (ica) using a neuron max 6f 088 long sheath (neuron max).It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician used the neuron max with no issue.However, upon completion of the procedure, while removing the neuron max the radio-opaque marker came off.Therefore, the physician pinned the radio-opaque marker to the internal green introducer and removed the neuron max containing the radio-opaque marker from the patient¿s body without incident.There was no adverse effect to the patient.
Additional Manufacturer Narrative
Results: the dilator was inserted through the neuron max through an rotating hemostasis valve (rhv).The atraumatic tip of the neuron max was folded over and the marker band was detached.The marker band was found on the od of the neuron max.The neuron max had a cut approximately 75.5 cm from the hub.Conclusions: evaluation of the returned neuron max revealed that the distal tip was folded back; the marker band was proximal to its initial position.The distal tip folding back likely contributed to the markerband detachment.The root cause of the distal tip folding was unable to be determined.Further evaluation revealed a cut on the neuron max body which was 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 MAX 6F 088 LONG SHEATH
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8022265
• Report Number: 3005168196-2018-02159
• Device Sequence Number: 16489506
• Product Code: DQY
• UDI-Device Identifier: 00814548012216
• UDI-Public: 00814548012216
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K111380
• 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): 10/02/2018
• 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: 01/05/2019
• Device Catalogue Number: PNML6F088804
• Device Lot Number: C09291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 03/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Date Report Sent to FDA: 01/01/2005