MAUDE Adverse Event Report: PENUMBRA, INC. NEURON 6F 053 DELIVERY CATHETER; DQY

Model Number	PND6F11512M
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2020
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 in the anterior cerebral artery (aca) using a neuron 6f 053 delivery catheter (neuron 053) and a non-penumbra microcatheter.During the procedure, the physician encountered resistance while attempting to advance the microcatheter through the proximal hub.The procedure was completed using another neuron 053 and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the neuron 053 was undamaged.Conclusions: evaluation of the returned neuron 053 revealed an undamaged, functional device.During functional testing, a demonstration lantern was advanced through the neuron 053 without an issue.No other devices associated with the complaint were returned for evaluation; therefore, the root cause of resistance experienced during the procedure could not be determined.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 6F 053 DELIVERY CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9832964
• Report Number: 3005168196-2020-00367
• Device Sequence Number: 10947755
• Product Code: DQY
• UDI-Device Identifier: 00814548010137
• UDI-Public: 00814548010137
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K070970
• 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
• Report Date (Section B): 02/19/2020
• 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: 01/08/2022
• Device Model Number: PND6F11512M
• Device Catalogue Number: PND6F11512M
• Device Lot Number: F87848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 03/14/2020
• Supplement Report FDA Received Date: 05/05/2020
• 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