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

Model Number 3MAXC-B

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2022

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure in the right middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3maxc), a neuron max 6f 088 long sheath (neuron max), a penumbra system red 72 reperfusion catheter (red72) and a non-penumbra guidewire.It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician completed two passes using the red72.During the third pass, the physician advanced the red72 to the face of the clot with aspiration and then removed the 3maxc.Upon removal of the 3maxc, it was noticed that the distal part of the 3maxc was missing.The red72 appeared to be kinked on the fluoroscopy.Therefore, the red72 was also removed from the patient.The broken piece of the 3maxc was found inside the red72; however, the red72 was not damaged.Subsequently, the physician used a syringe to remove the broken piece of 3maxc on the back table.Then, the physician completed two additional passes using a new 3maxc, the same red72 and the same neuron max.The thrombectomy was not successful due to low tici score; however, this was not due to any penumbra devices used in the procedure.There was no report of an adverse effect to the patient.

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.

Manufacturer Narrative

Evaluation of the returned 3maxc confirmed that the catheter was fractured.Evaluation revealed stretching at the fractured location.If the 3maxc is forcefully retracted against resistance, damage such as stretching and subsequent fracture may occur.The root cause of resistance could not be determined.Penumbra catheters are visually 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: PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER
• Type of Device: 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: 13404969
• MDR Text Key: 287421306
• Report Number: 3005168196-2022-00032
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548019956
• UDI-Public: 00814548019956
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,02/02/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2024
• Device Model Number: 3MAXC-B
• Device Catalogue Number: 3MAXC
• Device Lot Number: F108621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 01/04/2022
• Initial Date FDA Received: 01/31/2022
• Supplement Dates Manufacturer Received: 02/01/2022
• Supplement Dates FDA Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1