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

Model Number	PNML6F088904
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2020
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 underwent a medical procedure to place a stent using a neuron max 6f 088 long sheath (neuron max) and a non-penumbra sheath.After the procedure was completed, the physician had difficulty removing the neuron max.Upon removal of the neuron max, it was noticed on the back table that the neuron max had exposed wire.It was reported that the neuron max may have been fractured.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the returned neuron max was kinked at approximately 87.0 cm and 90.0 cm from the hub.The catheter was damaged at its distal shaft approximately 93.0 cm ¿ 94.0 cm from the hub and the coils inside the catheter were exposed.The distal tip was damaged.A portion of the markerband was fractured off from the catheter tip and not returned for evaluation.Conclusions: evaluation of the returned neuron max confirmed a distal shaft damage and the coils were exposed.If the device is forcefully retracted against resistance, damage such as this may occur.No other devices used in the procedure were returned for evaluation, therefore, the root cause of the resistance could not be determined.The complaint indicated that the neuron max was used to complete the procedure.Further evaluation of the neuron max revealed kinks.These kinks were likely incidental to the 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.

• 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: 9711912
• Report Number: 3005168196-2020-00175
• Device Sequence Number: 2353188
• Product Code: DQY
• UDI-Device Identifier: 00814548012179
• UDI-Public: 00814548012179
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 01/19/2020
• 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: 10/08/2022
• Device Model Number: PNML6F088904
• Device Catalogue Number: PNML6F088904
• Device Lot Number: H10093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/19/2020
• Supplement Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 04/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Date Report Sent to FDA: 01/01/2005