MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER; NRY

Catalog Number	RED72
Medical Device Problem Codes	Fracture (1260); Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72), a non-penumbra microcatheter, a non-penumbra sheath, and a guidewire.It should be noted that the patient''s anatomy was tortuous.During the procedure, while advancing the red72 over the microcatheter and the guidewire, the physician experienced resistance.It was reported that the physician continued to experience resistance as the red72 was advanced further.Therefore, the physician decided to remove the red72, microcatheter, and guidewire.While removing the red72, the physician also experienced resistance and upon removal, the physician noticed that the red72 was stretched and fractured mid-shaft.The procedure was completed using a penumbra system red 68 reperfusion catheter (red68) and the same sheath, microcatheter, and guidewire.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.
Additional Manufacturer Narrative
Please note that the following section was updated on this follow-up #01 mfr report: 3005168196-2023-00507.1.Section b.Box 5.Describe event or problem evaluation of the returned red72 confirmed that the catheter was stretched.This damage typically occurs due to retraction against resistance.The reported tortuous patient anatomy may have contributed to the resistance during the procedure.There was no visible fracture on the returned device.Further evaluation revealed a kink on the proximal shaft and multiple kinks on the distal shaft.Based on the reported event, the additional kinks on the distal shaft likely occurred due to advancement against resistance during the procedure.The proximal kink was incidental to the reported complaint and likely occurred during the packaging for the device return.Penumbra devices 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.Note: based on the investigation findings, this is not considered a reportable event.This event did not and, if it were to recur, it would not cause or contribute to serious injury or death.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72), a non-penumbra microcatheter, a non-penumbra sheath, and a guidewire.It should be noted that the patent's anatomy was tortuous.During the procedure, while advancing the red72 over the microcatheter and the guidewire, the physician experienced resistance.It was reported that the physician continued to experience resistance as the red72 was advanced further.Therefore, the physician decided to remove the red72, microcatheter, and guidewire.While removing the red72, the physician also experienced resistance and upon removal, the physician noticed that the red72 was stretched at the mid-shaft.The procedure was completed using a penumbra system red 68 reperfusion catheter (red68) and the same sheath, microcatheter, and guidewire.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM RED 72 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: 18116516
• Report Number: 3005168196-2023-00507
• Device Sequence Number: 12516526
• Product Code: NRY
• UDI-Device Identifier: 00815948023918
• UDI-Public: 815948023918
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K211654
• 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): 12/21/2023
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2026
• Device Catalogue Number: RED72
• Device Lot Number: H00001807
• 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: 10/19/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2023
• 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: 72 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005