MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 8; QEW

Catalog Number	SEP8
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
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.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left pulmonary artery (lpa) and right pulmonary artery (rpa) using an indigo system separator 8 (sep8) and an indigo system aspiration catheter 8 (cat8).During the procedure, the physician completed several passes in the target location using the sep8 and cat8.While removing the sep8, the physician observed under fluoroscopy that the wire distal to the bulb of the sep8 had fractured.The physician then attempted to aspirate the fractured part of the sep8 using the cat8, without success.The procedure was completed using a new sep8 and the same cat8.The final angiogram revealed that the fractured part of the sep8 remained in the distal lpa.The physician planned a later date for an echocardiogram and angiogram monitoring.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned sep8 confirmed that the device was fractured.If the sep8 is manipulated against resistance during use, the distal tip of the wire may become fatigued, and damage such as a kink and subsequent fracture may occur.Further evaluation revealed a kink in the core wire.This damage was incidental to the reported complaint and may have occurred during packaging of the device 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.H3 other text: placeholder.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra distributor on 16oct24: section b.Box 5.Describe event or problem.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left pulmonary artery (lpa) and right pulmonary artery (rpa) using an indigo system separator 8 (sep8) and an indigo system aspiration catheter 8 (cat8).During the procedure, the physician completed several passes in the target location using the sep8 and cat8.While removing the sep8, the physician observed under fluoroscopy that the wire distal to the bulb of the sep8 had fractured.The physician then attempted to aspirate the fractured part of the sep8 using the cat8, without success.The procedure was completed using a new sep8 and the same cat8.The final angiogram revealed that the fractured part of the sep8 remained in the distal lpa.The physician planned a later date for an echocardiogram and angiogram monitoring.There was no report of an adverse effect to the patient.The patient stayed in the hospital for thrombolysis treatment 3 days before performing a dual pulmonary embolism (pe) aspiration post-thrombolysis with a cat8 and sep8.The patient was continued on low dose thrombolysis another 7 days before being discharged back home.

• Brand Name: INDIGO SYSTEM SEPARATOR 8
• 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: 17940896
• Report Number: 3005168196-2023-00464
• Device Sequence Number: 12362568
• Product Code: QEW
• UDI-Device Identifier: 00815948022980
• UDI-Public: 815948022980
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K161523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2024
• 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 Expiration Date: 01/10/2026
• Device Catalogue Number: SEP8
• Device Lot Number: H00001872
• 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: 09/20/2023
• Supplement Date Received by Manufacturer: 12/08/2023; 10/16/2024
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 01/05/2024; 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2023
• 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
• Patient Age: 80 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005