MAUDE Adverse Event Report: PENUMBRA, INC. NEURON 6F 070 DELIVERY CATHETER; DQY

Catalog Number	PND6F0701058M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2022
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 medical procedure in the left posterior inferior cerebellar artery (pica) using a neuron 6f 070 delivery catheter (neuron 070) and a non-penumbra short sheath.During the procedure, after introducing the neuron 070 via the short sheath, the physician noticed that the proximal end close to the hub of the neuron 070 was broken.Subsequently, it was noticed that some blood and saline came out of the broken part of the neuron 070.Therefore, the neuron 070 was removed.The procedure was completed using a new neuron 070 and the same short sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned neuron 070 confirmed that the catheter was fractured.If the neuron 070 is manipulated at an extreme angle during use, damage such as a kink and subsequent fracture may occur.Further evaluation revealed an ovalization on the catheter shaft.This damage was incidental to the reported complaint and the root cause 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.

• Brand Name: NEURON 6F 070 DELIVERY CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 14661238
• Report Number: 3005168196-2022-00277
• Device Sequence Number: 20317740
• Product Code: DQY
• UDI-Device Identifier: 00814548010052
• UDI-Public: 814548010052
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2022
• 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: 01/28/2024
• Device Catalogue Number: PND6F0701058M
• Device Lot Number: F103568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• 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: 05/27/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005