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

Catalog Number	3MAXC
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2022
Type of Reportable Event	Malfunction
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 non-penumbra catheter, a non-penumbra sheath, and a guidewire.It was noted that the patient¿s anatomy was tortuous with two 360-degree loops and had hard plaque.During the procedure, the physician successfully completed one pass in the target vessel using the 3maxc, catheter, and sheath.While retracting the 3maxc to remove it from the patient, the physician experienced resistance and noticed under fluoroscopy that the 3maxc broke near the ophthalmic vessel while the distal tip was in the m1.Subsequently, the physician removed the proximal piece of the 3maxc and aspirated the broken distal piece of the 3maxc out of the patient using the catheter.The physician decided to end the procedure at this point as the physician was unable to get past the plaque using the 3maxc.It was also reported that the patient¿s family did not want intravenous (iv) tissue plasminogen activator (tpa) administered to the patient.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned penumbra system 3max reperfusion catheter (3maxc) confirmed that the catheter was fractured.Evaluation revealed that the 3maxc was stretched.If the 3maxc is retracted against resistance during use, damage such as stretching and subsequent fracture may occur.The patient tortuous anatomy may have contributed to resistance during the procedure.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
• 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: 14215241
• Report Number: 3005168196-2022-00192
• Device Sequence Number: 4193969
• Product Code: NRY
• UDI-Device Identifier: 00814548019956
• UDI-Public: 814548019956
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K160449
• 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
• Report Date (Section B): 04/26/2022
• 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: 11/15/2024
• Device Catalogue Number: 3MAXC
• Device Lot Number: F110780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2022
• 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: 04/02/2022
• Initial Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2021
• 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: 75 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005