MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER; NRY

Catalog Number	RED62SKIT
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please note that this complaint was submitted to the fda by the user facility with the following reference number:mw5155689.The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 right m2 segment of the middle cerebral artery (mca) using a penumbra system red 62 reperfusion catheter (red62), a non-penumbra microcatheter, a non-penumbra long sheath, an intra-arterial blood pressure monitor device, and a guidewire.It was reported that the patient¿s anatomy was tortuous with a loop in the lower cervical region of the internal carotid artery (ica).During the procedure, the physician placed the long sheath proximal to the loop in the ica.The red62 and the microcatheter were advanced over the guidewire through the sheath into the target location.The physician completed one pass using the red62.While retracting the red62, the physician noticed that the distal part of the red62 remained in the carotid terminus.As the physician continued to retract the red62, it was noted that there was a wire being pulled out and the wire was completely removed from the long sheath.The physician then noticed that the red62 fractured at the distal length.The fractured portion of the red62 remained in the vessel and multiple attempts were made to retrieve the fractured part of the red72 using a snare device (6f, 100cm) through the tortuous anatomy without success.A penumbra system red 72 reperfusion catheter (red72), two stent retrievers, and another guidewire were advanced to the target location.The physician then attempted to complete three passes using the stent retrievers; however, the clot could not be removed.The procedure ended at this point.It was reported that there were no plans to remove the fractured part of the red62.The patient¿s current medical status is unknown.

• Brand Name: PENUMBRA SYSTEM RED 62 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: 19639930
• Report Number: 3005168196-2024-00229
• Device Sequence Number: 8610388
• Product Code: NRY
• UDI-Device Identifier: 00815948023536
• UDI-Public: 00815948023536
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K203440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2024
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RED62SKIT
• Device Lot Number: H00004842
• Was Device Available for Evaluation?: No
• 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: 05/29/2024
• Initial Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005