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

Catalog Number	RED72KIT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica), the middle cerebral artery (mca), and the anterior cerebral artery (aca) using a penumbra system red 72 reperfusion catheter (red72), a benchmark bmx96 access system (bmx96), a non-penumbra microcatheter and a guidewire.During the procedure, the physician completed two passes using the red72.While retracting the red72 after completion of the second pass, the red72 broke in half.Subsequently, the physician noticed under fluoroscopy the distal piece of the red72 remained in the patient.It was reported the patient¿s anatomy was tortuous and calcified.Therefore, a snare device was used to remove the distal piece of the red72.The procedure was completed at this point.There was no report of an adverse effect to the patient.
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:3005168196-2023-00114 1.Section b.Describe event or problem evaluation of the returned red72 confirmed that the catheter was fractured on the distal shaft.Evaluation revealed that the red72 was stretched distal to the fracture.This indicated that the device was stretched prior to fracture.If the red72 is retracted against resistance, it may become stretched and subsequently fracture.The complaint reported that the patient¿s anatomy was tortuous and calcified.It was also reported that the red72 became wedged between plaque and the tip of the bmx96.This may have contributed to the resistance during the retraction of the device.Further evaluation of the device revealed kinks and ovalizations on the proximal and the distal fractured segment.This damage was likely incidental to the complaint and may have occurred during snaring or handling of the device post-procedure.Penumbra products 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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica), the middle cerebral artery (mca), and the anterior cerebral artery (aca) using a penumbra system red 72 reperfusion catheter (red72), a benchmark bmx96 access system (bmx96), a non-penumbra microcatheter and a guidewire.It was reported the patient¿s anatomy was tortuous and calcified.During the procedure, the physician completed two passes using the red72.While retracting the red72 after completion of the second pass, the red72 broke in half.It was reported that the red72 may have become wedged between the plaque and the tip of the bmx96.Subsequently, the physician noticed under fluoroscopy the distal end of the red72 remained in the patient.Therefore, a snare device was used to remove the distal piece of the red72.The procedure was completed at this point.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: 16583078
• Report Number: 3005168196-2023-00114
• Device Sequence Number: 4693995
• Product Code: NRY
• UDI-Device Identifier: 00815948023932
• UDI-Public: 815948023932
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K211654
• 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,Followup
• Report Date (Section B): 06/28/2023
• 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: 07/25/2025
• Device Catalogue Number: RED72KIT
• Device Lot Number: H00000778
• 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: 02/23/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2022
• 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 Age: 68 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Date Report Sent to FDA: 01/01/2005