MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 12; QEW

Catalog Number	LITNG12HTORQ100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Therefore, a physical device investigation was unable to be performed.The product lot number was not provided; therefore, the manufacturing records could not be reviewed.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.
Event or Problem Description
On (b)(6) 2024, the patient underwent a thrombectomy procedure to treat a pulmonary embolism (pe) after knee surgery using an indigo system aspiration catheter 12 (cat12).There were no reported procedural complications.On (b)(6) 2024, the patient¿s hemoglobin level was 6.9 g/dl and the patient was bleeding from the surgical wound.The patient was administered a reduced dose of anticoagulation and transfusion of four units of blood.On (b)(6) 2024, an inferior vena cava (ivc) filter was implanted.The event is considered resolved.The independent medical reviewer (imr) adjudicated the bleeding from the surgical wound as a serious adverse event with a possible relationship to the indigo system aspiration catheter 12 and index procedure.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 12
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 20797474
• Report Number: 3005168196-2024-00396
• Device Sequence Number: 18090578
• Product Code: QEW
• UDI-Device Identifier: 00815948022904
• UDI-Public: 00815948022904
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K202821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: LITNG12HTORQ100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 73 YR
• Patient Sex: Female