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

Catalog Number	PNS5F130SIM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
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 using a neuron select catheter 5f (5f select) and a guidewire.During the procedure, while advancing the 5f select in the bovine arch, the physician noticed under fluoroscopy that the distal end of the 5f select broke into three parts inside the patient.The physician then used a snare device and removed the broken parts; however, a small piece was left in the m2 branch and the physician was unable to retrieve it.The procedure ended at this point.It was reported that the patient''s condition is unstable.No additional information is available at this point.
Additional Manufacturer Narrative
Evaluation of the returned 5f select confirmed that the catheter was fractured.This damage typically occurs due to retraction against resistance.Based on the damage at the fractured location, the 5f select may have been retracted against resistance during use.Further evaluation revealed additional fractures and damage on the distal segments.This damage may have occurred during the snaring process and removal from the patient.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.
Additional Manufacturer Narrative
The following sections are being updated based on additional information provided in a post-operative report received on april 4, 2023: section a.Box 2.Date of birth.Section b.Box 5.Describe event or problem.The following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report 3005168196-2023-00143; based on additional information provided in a post-operative report received on april 4, 2023: section a.Box 1.Patient identifier.Section a.Box 2.Age at time of event.Section h.Box 10./11.Narrative/corrected data.Evaluation of the returned 5f select confirmed that the catheter was fractured.This damage may have occurred due to unrestrained moving or torqueing against resistance.Navigation within difficult anatomy may have contributed to increased resistance.Evaluation also confirmed the two fractured segments measuring approximately 5 cm and 2 cm reported to have occurred during removal through the non-penumbra 6f sheath.The 2 cm fractured segment included the intact distal tip of the catheter.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.
Event or Problem Description
Penumbra received additional information via a post-operative report on april 4, 2023.A diagnostic procedure was performed to visualize a cerebellar avm using a neuron select catheter 5f (5f select).The 5f select was advanced to the target anatomy via radial access through a short sheath with use of a 0.035 guidewire.The 5f select was navigated to the lva, lcca, leca, and lica and angiograms were performed in each vessel respectively.The 5f select was visualized for removal from the lica when it was noticed the 5f select had fractured resulting in two loose segments.At this point, a snare was introduced through the 5f select.During advancement of the snare to the lica in attempt to snare the larger segment, the smaller segment dislodged and migrated to the m2/m3.The snare and 5f select were removed from the radial access site.The right common femoral artery (rcfa) was then accessed and a benchmark bmx96 access system (bmx96) and 5 french non-penumbra catheter were introduced into the left common carotid artery (lcca).A snare was introduced through the diagnostic catheter to snare the larger segment.The larger segment was retracted into the rcfa but could not be removed.A non-penumbra microcatheter was introduced to navigate to the fractured segment in the m2.A non- penumbra revascularization device was used in attempt to remove the fragment but was unsuccessful.A penumbra system red 72 reperfusion catheter (red72) and a penumbra system red 62 reperfusion catheter (red62) were both used in attempt to aspirate the fragment from the m2 but were unsuccessful.A 4mm snare was then used in an attempt to remove the fractured segment but was unsuccessful.A super selective angiogram showed sufficient flow to distal mca branches past the fractured segment in the m2/m3.The decision was made to leave the fractured segment.The bmx96 system was removed.Imaging was performed through the radial access point.A non-penumbra 6f sheath was introduced through the femoral access point to snare the fragment remaining in the rcfa.The fractured segment was retracted into the non-penumbra sheath and fractured into two pieces within the sheath during removal.The procedure was completed at this point.The post-operative report indicated the patient was stable after the procedure.Subsequently, information from the physician indicated that the patient¿s status was unstable.It is unknown how the reported event may have impacted the patient¿s status.

• 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: 16659269
• Report Number: 3005168196-2023-00143
• Device Sequence Number: 11187587
• Product Code: DQY
• UDI-Device Identifier: 00814548010236
• UDI-Public: 814548010236
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2023
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/20/2024
• Device Catalogue Number: PNS5F130SIM
• Device Lot Number: F106485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 03/24/2023; 04/04/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 04/10/2023; 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2021
• 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: Male
• Date Report Sent to FDA: 01/01/2005