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

Catalog Number	SEP12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemoptysis (1887)
Date of Event	11/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2023-00556.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat a pulmonary embolism using an indigo system cat12 aspiration catheter (cat12), a lightning aspiration tubing (lightning), an indigo system separator 12 (sep12), and a penumbra engine (engine).During the procedure, the physician treated the left lung by removing the thrombus under aspiration using the cat12 and sep12.Shortly before the end of the procedure, the patient started coughing blood.The physician then noticed bleeding from a capillary in the left lung, indicating a vascular rupture.The patient was then ventilated, and it was reported that the bleeding stopped relatively quickly without any treatment.The procedure ended at this point.The patient''s current health status is good, with spontaneous breathing the day after the procedure.The relationship between hemoptysis, the cat12 and sep12 is unknown.
Additional Manufacturer Narrative
From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Hemoptysis is included as a possible complication in the instructions for use (ifu) for the indigo aspiration system.Evaluation of the returned sep12 revealed an undamaged device.There was no reported allegation against sep12.The sep12 was able to advance through the returned cat12 without an issue during evaluation.Penumbra devices 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: 1.3005168196-2023-00556.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat a pulmonary embolism using an indigo system cat12 aspiration catheter (cat12), a lightning aspiration tubing (lightning), an indigo system separator 12 (sep12), and a penumbra engine (engine).During the procedure, the physician treated the left lung by removing the thrombus under aspiration using the cat12 and sep12.Shortly before the end of the procedure, the patient started coughing blood.The physician then noticed bleeding from a capillary in the left lung.The patient was then ventilated, and it was reported that the bleeding stopped relatively quickly without any treatment.The procedure ended at this point.The patient's current health status is good, with spontaneous breathing the day after the procedure.The relationship between hemoptysis, the cat12 and sep12 is unknown.

• Brand Name: INDIGO SYSTEM SEPARATOR 12
• Common Device Name: QEW
• 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: 18351252
• Report Number: 3005168196-2023-00557
• Device Sequence Number: 5341568
• Product Code: QEW
• UDI-Device Identifier: 00815948021549
• UDI-Public: 815948021549
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K202821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/20/2026
• Device Catalogue Number: SEP12
• Device Lot Number: H00002410
• 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: 11/21/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005