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

Model Number	PNS6F125SIM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2021
Type of Reportable Event	Serious Injury
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 right common carotid artery using a neuron select catheter 6f (6f select), a neuron max 6f 088 long sheath (neuron max) and a guidewire.During the procedure, while advancing a 6f select over a guidewire through the neuron max in the aortic arch, the distal end of the 6f select broke off and migrated through the descending aorta to the left iliac femoral bifurcation.The physician then removed the neuron max and 6f select.Next, the physician inserted a non-penumbra diagnostic catheter for selective carotid access, then advanced the guidewire.The non-penumbra diagnostic catheter was then removed and the same neuron max was positioned in the distal right common carotid artery to perform a coil embolization using a non-penumbra distal access catheter and a microcatheter.Afterwards, while removing the broken piece of the 6f select using a non-penumbra loop catheter in an endovascular procedure, the broken piece of the 6f select broke into three pieces.Subsequently, it was noted that the broken pieces traveled down and occluded the left superficial femoral artery and deep femoral artery.The broken pieces of the 6f select were then removed and an angioplasty was performed for adequate reperfusion of the left lower limb.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device associated with this complaint was expected to be returned; however, the device was lost in transit and is no longer available for return.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
Please note that the device in complaint was not expected to be returned; however, on 06-dec-2021 the device was received.Based on this information, corrections were made to: 1.Section d.Box 10: device available for evaluation? (do not send to fda).2.Section h.Box 3: device returned to manufacturer? 3.Section h.Box 3: device evaluated by manufacturer? 4.Section h.Box 6: method code 1 and method code 2, and method code 3.5.Section h.Box 6: results code 1.6.Section h.Box 6: conclusions code 1.Evaluation of the returned 6f select confirmed a distal shaft fracture.If the device is forcefully manipulated against resistance during use, damage such as a fracture may occur.The fractured distal segment was not returned for evaluation.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 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: 12422651
• Report Number: 3005168196-2021-01958
• Device Sequence Number: 3516276
• Product Code: DQY
• UDI-Device Identifier: 00814548012070
• UDI-Public: 00814548012070
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• PMA/510(K) Number: K083125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2022
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/14/2022
• Device Model Number: PNS6F125SIM
• Device Catalogue Number: PNS6F125SIM
• Device Lot Number: F90292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/11/2021
• Supplement Date Received by Manufacturer: 10/20/2021; 12/10/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 10/27/2021; 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2019
• 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