MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER; NRY

Catalog Number	3MAXC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Foreign Body Embolism (4439)
Date of Event	12/05/2022
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.Placeholder.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3maxc), a penumbra system red 72 reperfusion catheter (red72), and a benchmark bmx96 access system (bmx96).During the procedure, while removing the 3maxc from the red72, it was noticed that the distal end of the 3maxc had broken off and was found in the carnivorous segment of the carotid artery.The physician made multiple attempts to remove the broken distal end of the 3maxc but was unsuccessful.The procedure ended at this point.The patient was then sent to cranial computed tomography (ct) and for neuro intensive care unit (icu).The patient current health status is unknown.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra distributor on 24 feb 23: 1.Section b.Box 5.Describe event or problem evaluation of the returned 3maxc confirmed that the device was fractured.Evaluation revealed that the catheter was stretched proximal to the fracture.This indicates the fracture was likely the result of retraction against resistance.If the 3maxc is retracted against resistance, the device may become stretched and subsequently fracture.The root cause of resistance could not be determined.The fractured distal portion of the 3maxc 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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3maxc), a penumbra system red 72 reperfusion catheter (red72), a benchmark bmx96 access system (bmx96), and a guidewire.It was noted that the patient presented with motor deficit, language alteration and the cranial tomography showed mild left temporal ischemia.During the procedure, the physician inserted the bmx96 into the patient.The physician then advanced the red72 through the bmx96 and into the target vessel using the 3maxc and guidewire.After that, the 3maxc and guidewire were removed.Next, while attempting to advance the red72 against the thrombus, the physician noticed under fluoroscopy that the 3maxc had fractured and a fragment of the 3maxc remained within in the red72.The physician then decided to use the solumbra technique to capture the thrombus and the fragment of the 3maxc.However, while attempting to position a microcatheter and the guidewire into the m2 segment of the mca to deliver the stent retriever, the distal end of the 3maxc fragment started to concomitantly advance towards the m2 segment of the mca.Next, while attempting to intertwine the fragment of the 3maxc in the stent retriever, the distal end of the 3maxc fragment advanced into the m2 segment of the mca.It was reported that the distal end of the 3maxc fragment appeared bent.Next, the microcatheter, guidewire, stent retriever and red72 were removed.It was reported that partial removal of the thrombus was achieved.Upon removal of the red72, it was noticed that the fragment of the 3maxc extended into the cavernous segment of the internal carotid artery (ica).After examining the part of the 3maxc that was already removed, it was reported that approximately 12.5 centimeters of the 3maxc was left in the patient.The physician made multiple attempts to remove the 3maxc fragment from the patient using a stent retriever and a snare device but was unsuccessful.It was reported that during the removal attempts, the distal end of the 3maxc fragment that was bent into the m2 segment of the mca and would not move.The physician then decided to leave the 3maxc fragment in the patient and treat the patient with dual antiplatelet agents.The computed tomography (ct) scan performed after the procedure showed discrete temporal ischemia without signs of hemorrhage.The 24 hours ct scan showed only temporal ischemia.It was also reported that the patient was lucid and conscious but remained with hemiplegia and aphasia.There was no report of an effect to the patient related to the 3maxc.
Additional Manufacturer Narrative
Ischemia is included as a possible complication in the instructions for use (ifu) for the penumbra system.Evaluation of the returned 3maxc confirmed that the device was fractured.Evaluation revealed that the catheter was stretched proximal to the fracture.This indicates the fracture was likely the result of retraction against resistance.If the 3maxc is retracted against resistance, the device may become stretched and subsequently fracture.The root cause of resistance could not be determined.The fractured distal portion of the 3maxc 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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3maxc), a penumbra system red 72 reperfusion catheter (red72), a benchmark bmx96 access system (bmx96), and a guidewire.It was noted that the patient presented with motor deficit, language alteration and the cranial tomography showed mild left temporal ischemia.During the procedure, the physician inserted the bmx96 into the patient.The physician then advanced the red72 through the bmx96 and into the target vessel using the 3maxc and guidewire.After that, the 3maxc and guidewire were removed.Next, while attempting to advance the red72 against the thrombus, the physician noticed under fluoroscopy that the 3maxc had fractured and a fragment of the 3maxc remained within the red72.The physician then decided to use the solumbra technique to capture the thrombus and the fragment of the 3maxc.However, while attempting to position a microcatheter and the guidewire into the m2 segment of the mca to deliver the stent retriever, the distal end of the 3maxc fragment started to concomitantly advance towards the m2 segment of the mca.Next, while attempting to intertwine the fragment of the 3maxc in the stent retriever, the distal end of the 3maxc fragment advanced into the m2 segment of the mca.It was reported that the distal end of the 3maxc fragment appeared bent.Next, the microcatheter, guidewire, stent retriever and red72 were removed.It was reported that partial removal of the thrombus was achieved.Upon removal of the red72, it was noticed that the fragment of the 3maxc extended into the cavernous segment of the internal carotid artery (ica).After examining the part of the 3maxc that was already removed, it was reported that approximately 12.5 centimeters of the 3maxc was left in the patient.The physician made multiple attempts to remove the 3maxc fragment from the patient using a stent retriever and a snare device but was unsuccessful.It was reported that during the removal attempts, the distal end of the 3maxc fragment that was bent into the m2 segment of the mca and would not move.The physician then decided to leave the 3maxc fragment in the patient and treat the patient with dual antiplatelet agents.The computed tomography (ct) scan performed after the procedure showed discrete temporal ischemia without signs of hemorrhage.The 24 hours ct scan showed only temporal ischemia.It was also reported that the patient was lucid and conscious but remained with hemiplegia and aphasia.

• Brand Name: PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
• Common Device Name: NRY
• 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: 16117014
• Report Number: 3005168196-2023-00014
• Device Sequence Number: 6867308
• Product Code: NRY
• UDI-Device Identifier: 00814548019956
• UDI-Public: 814548019956
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K160449
• 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): 04/26/2023
• 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: 07/21/2024
• Device Catalogue Number: 3MAXC
• Device Lot Number: F107878
• 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: 12/13/2022
• Supplement Date Received by Manufacturer: 01/30/2023; 01/14/2005
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 02/28/2023; 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005