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

Catalog Number	3MAXC
Medical Device Problem Codes	Stretched (1601); Unraveled Material (1664); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system 3max reperfusion catheter (3maxc), a penumbra system ace 68 reperfusion catheter (ace68), and a guide catheter.During the procedure, the physician attempted to advance the ace68 over the 3maxc through the guide catheter to the target vessel.However, the 3maxc would not advance past a segment of the internal carotid artery (ica).Therefore, the physician decided to remove the 3maxc and switch to a stent retriever.Upon removal of the 3maxc, the physician noticed that the 3maxc was stretched and unraveled.The procedure was completed using the stent retriever.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The product was not returned for evaluation.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.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2022-00382 1.Section a.Box 1.Patient identifier: should be left blank.Please note that the following section is being updated based on additional information provided by the distributor on 09/09/2022: 1.Section b.Box 5.Describe event or problem.H3 other text: placeholder.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3maxc), a penumbra system ace 68 reperfusion catheter (ace68), a neuron max 6f 088 long sheath (neuron max), and a guidewire.It was reported that the patient¿s anatomy was tortuous.During the procedure, the physician advanced the neuron max into the patient, then advanced the ace68 through the neuron max and into the target vessel using the 3maxc and guidewire.Next, the 3maxc and guidewire were removed and the physician successfully completed one pass.After completion of the first pass, the ace68 was removed.Subsequently, the physician attempted to re-advance the ace68 through the neuron max using the 3maxc; however, resistance was encountered and the 3maxc would not advance past a segment of the internal carotid artery (ica).Therefore, the physician decided to remove the 3maxc and switch to a stent retriever.While retracting the 3maxc, resistance was also encountered.Upon removal of the 3maxc, the physician noticed that the distal end of the 3maxc was stretched and unraveled.It was reported that saline was flushed through the neuron max and ace68 while attempting to advance the 3maxc.The procedure was completed using the stent retriever, the same ace68, and the same neuron max.There was no report of an adverse effect to the patient.

• 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: 15254966
• Report Number: 3005168196-2022-00382
• Device Sequence Number: 12434319
• Product Code: NRY
• UDI-Device Identifier: 00814548019956
• UDI-Public: 814548019956
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 09/20/2022
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2025
• Device Catalogue Number: 3MAXC
• Device Lot Number: F113337
• 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: 07/22/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2022
• 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 Sex: Female
• Date Report Sent to FDA: 01/01/2005