MAUDE Adverse Event Report: PENUMBRA, INC. NEURON SELECT CATHETER 5F; DQY

Model Number	BMK6F95BER120
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a medical procedure to treat a bifurcation aneurysm in the anterior communicating artery (acom) using a neuron select catheter 5f (5f select), a benchmark 6f 071 delivery catheter (benchmark), and a contour device.During the procedure, while delivering the 5f select and benchmark to the target location, the distal tip of the 5f select broke and was dislodged.Therefore, the physician used a snare device to retrieve the tip of the 5f select.The procedure was completed using a neuron max 6f 088 long sheath (neuron max), a non-penumbra microcatheter, and the same contour device.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device in complaint was expected to be returned; however, the manufacturer has made multiple attempts to follow up for the product return but was unsuccessful.Therefore, 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.H3 other text : placeholder.
Additional Manufacturer Narrative
Evaluation of the first returned 5f select confirmed, a fracture on the distal shaft.If the device is retracted against resistance during use, damage such as a fracture may occur.Further evaluation of the 5f select revealed, a kink on the proximal end and kinks on the distal shaft.The distal kinks were likely, a result of the fractured piece being removed using a snare.The proximal kink 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 SELECT CATHETER 5F
• 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: 11049799
• Report Number: 3005168196-2020-02326
• Device Sequence Number: 14093372
• Product Code: DQY
• UDI-Device Identifier: 00814548014128
• UDI-Public: 00814548014128
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K083125
• 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,Followup
• Report Date (Section B): 11/24/2020
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2020
• Device Model Number: BMK6F95BER120
• Device Catalogue Number: BMK6F95BER120
• Device Lot Number: F80928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• 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: 11/24/2020
• Supplement Date Received by Manufacturer: 01/14/2005; 11/24/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 05/26/2021; 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005