MAUDE Adverse Event Report: PENUMBRA, INC. NEURON DELIVERY CATHETER 070; DQY

Model Number	PND6F0701058M
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 1.3005168196-2020-00619.
Event or Problem Description
The patient was undergoing a medical procedure to treat a brain embolization using neuron max 6f 088 long sheaths (neuron max) and a neuron 6f 070 delivery catheter (neuron 070).During the procedure, prior to use, the hospital staff noticed that the distal end of a neuron max was damaged and had sign of corrosion and cracks upon opening of the packaging.The damage to the neuron max was found prior to use and therefore, the neuron max was not used in the procedure.The physician then opened a new neuron max and attempted to advance the neuron 070 into the neuron max; however, resistance was encountered after advancing the neuron 070 approximately three centimeters into the new neuron max and the neuron 070 would not advance further.Therefore, the neuron max and neuron 070 were removed.The physician then advanced the neuron 070 into a non-penumbra sheath; however, the same issue occurred and the neuron 070 was therefore removed.The procedure was completed using the same sheath and another catheter.There was no report of an adverse effect to the patient.

• Brand Name: NEURON DELIVERY CATHETER 070
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10040430
• Report Number: 3005168196-2020-00620
• Device Sequence Number: 2813340
• Product Code: DQY
• UDI-Device Identifier: 00814548010052
• UDI-Public: 00814548010052
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K082290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/17/2020
• 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: 07/25/2022
• Device Model Number: PND6F0701058M
• Device Catalogue Number: PND6F0701058M
• Device Lot Number: F92078
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 05/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Date Report Sent to FDA: 01/01/2005