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

Catalog Number	BMX9690BER125
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
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 coil embolization procedure in the internal carotid artery (ica), middle cerebral artery (mca), and anterior cerebral artery (aca) using a benchmark bmx96 access system (bmx96), neuron select catheter 6f (6f select), and a non-penumbra microcatheter.After successful completion of the procedure, while advancing the bmx96 containing the 6f select into the origin of the left vertebral artery to perform an angiogram of the posterior anatomy, the distal end of the 6f select broke off in the subclavian artery and was stuck.The procedure ended at this point.The patient was then taken to surgery to remove the remaining broken distal end of the 6f select.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient underwent a coil embolization procedure in the internal carotid artery (ica), middle cerebral artery (mca), and anterior cerebral artery (aca) using a benchmark bmx96 access system (bmx96), neuron select catheter 6f (6f select), and a non-penumbra microcatheter.After successful completion of the procedure, the bmx96 containing the 6f select was advanced into the left vertebral artery to perform an angiogram.The 6f select fractured in the subclavian artery and became was stuck.A snare device was used to remove the 6f select; however, the catheter continued to fracture into smaller fragments.The patient was then taken to surgery to remove the remaining fragments of the 6f select.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that this complaint was submitted to the fda by the user facility with the following reference number: mw5115938.Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #02 mfr report: 3005168196-2023-00127.1.Section b.Box 1.Adverse event and/or product problem.2.Section b.Box 2.Outcomes attributed to adverse event.3.Section g.Box 4.Date received by manufacturer.4.Section h.Box 1.Type of reportable event.5.Section h.Box 6.Conclusions code 1 & conclusions code 2.The following sections are being updated based on additional information included in the user facility report submitted to the fda: 1.Section b.Box 5.Describe event or problem.2.Section e.Box 4.Initial reporter also sent report to fda.3.Section g.Box 3.Report source h3 other text : placeholder.
Additional Manufacturer Narrative
Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was disposed of and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: NEURON SELECT CATHETER 6F
• 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: 16588488
• Report Number: 3005168196-2023-00127
• Device Sequence Number: 17616195
• Product Code: DQY
• UDI-Device Identifier: 00815948022645
• UDI-Public: 815948022645
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K083125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2023
• 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: 11/18/2023
• Device Catalogue Number: BMX9690BER125
• Device Lot Number: F102135
• Was Device Available for Evaluation?: No
• 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: 02/24/2023
• Supplement Date Received by Manufacturer: 07/24/2023; 03/28/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 07/26/2023; 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2020
• 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 Sex: Female
• Date Report Sent to FDA: 01/01/2005