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

Model Number	PNML6F088904M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2020
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
The patient was undergoing a coil embolization procedure using a neuron max 6f 088 long sheath (neuron max).During the procedure, while torquing the neuron max, the distal tip appeared damaged on the angiogram; therefore, it was removed.Upon removal, the distal end of the neuron max was observed to be broken.The procedure was completed using another neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 03/27/2020: section b.Box 5.Describe event or problem.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using a neuron max 6f 088 long sheath (neuron max) and non-penumbra sheath.It was reported that the patient''s anatomy was tortuous.During the procedure, while torqueing the neuron max through the sheath, the distal tip of the neuron max appeared damaged on the angiogram; therefore, it was removed.Upon removal, the distal end of the neuron max was observed to be broken.The procedure was completed using another neuron max.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned neuron max revealed a stretch on the distal shaft.This damage is likely the reported break on the distal end.The reported torqueing of the device within the tortuous patient anatomy may have contributed to this damage.Further evaluation revealed a kink near the hub.This damage was likely incidental to the reported complaint.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.H3 other text : placeholder.

• 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: 9740168
• Report Number: 3005168196-2020-00234
• Device Sequence Number: 1802747
• Product Code: DQY
• UDI-Device Identifier: 00814548012162
• UDI-Public: 00814548012162
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• 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,Followup,Followup
• Report Date (Section B): 01/25/2020
• 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: 04/08/2022
• Device Model Number: PNML6F088904M
• Device Catalogue Number: PNML6F088904M
• Device Lot Number: F89495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/25/2020
• Supplement Date Received by Manufacturer: 03/27/2020; 02/22/2021
• Initial Report FDA Received Date: 02/21/2020
• Supplement Report FDA Received Date: 09/16/2020; 02/24/2021
• 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