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

Catalog Number	RED72SDKIT
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2024
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 red72 reperfusion catheter (red72), a sendit delivery device (sendit), and a benchmark bmx96 access system (bmx96) and a guidewire.During the procedure, the red72 was advanced with the sendit to the target location.The sendit was removed, and the physician attempted to advance the red72 to the clot interface; however, the red72 would not advance.The physician decided to remove the red72.While the red72 was being removed from the sheath, the red72 unraveled.It was reported that the red72 and the bmx96 were removed completely.The procedure was completed using a new red72, a new sendit, and the same bmx96.On 5-june-2024, a clinical notification was received indicating emboli infarct in a new territory anterior cerebral artery (aca) was noticed during the procedure.It was reported that the patient had a fetal type of variant posterior communicating artery (pca).Emboli infarct was reported to be a serious adverse event with a possible relationship to the penumbra system and a possible relationship to the index procedure.The patient was administered anticoagulant medication and was transferred to a skilled nursing facility.
Additional Manufacturer Narrative
Evaluation of the returned red72 confirmed the distal shaft fracture and unraveled coil winds at the fractured location.If the catheter is retracted against resistance, the device will likely stretch.If continually retracted against resistance, the stretch portion may ultimately fracture.Based on the reported event, the unraveled internal coils likely occurred during retraction of the fractured device from the sheath.Evaluation of the returned red72 revealed a kink and ovalization on the proximal end, and an ovalization at the catheter distal tip.Further evaluation revealed that the red 72 was returned with the unraveled internal coil winds through an rhv and the ovalizations noticed on the catheter appeared visually identical.Therefore, the ovalizations may have occurred due to overtightening of the rhv or forcefully griping the device and may have contributed to the resistance experienced during retraction.The kink was likely incidental to the complaint and may have occurred during packaging for return to penumbra.Penumbra catheters are 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.This report is associated with mfr report number: 1.3005168196-2024-00227.

• 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: 19581976
• Report Number: 3005168196-2024-00226
• Device Sequence Number: 3266494
• Product Code: NRY
• UDI-Device Identifier: 00815948025943
• UDI-Public: 00815948025943
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K211654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2024
• 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 Catalogue Number: RED72SDKIT
• Device Lot Number: F00010664
• Was Device Available for Evaluation?: Yes
• 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: 05/24/2024
• Initial Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2024
• 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: 57 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005