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

Catalog Number	CAT8XTORQ115KIT
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2024
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the pulmonary artery using an indigo system aspiration catheter 8 (cat8), a non-penumbra sheath, and a guidewire.It should be noted that the patient's anatomy was tortuous.During the procedure, the physician experienced resistance while introducing the cat8 into the target vessel.It was reported that there was an issue while attempting to aspirate with the cat8.Therefore, the physician decided to remove the cat8.Upon removal of the cat8, the physician found that the cat8 was fractured at the distal length.Therefore, the sheath and the remaining fragment of the cat8 were removed from the patient together.The procedure was ended at this point and the physician plans to continue the procedure at a later date.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was updated for clarification: 1.Section b.Box 5.Describe event or problem.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the pulmonary artery using an indigo system aspiration catheter 8 (cat8), a non-penumbra sheath, and a guidewire.It should be noted that the patient's anatomy was tortuous.During the procedure, the physician experienced resistance while introducing the cat8 into the target vessel.It was reported that there was an issue while attempting to aspirate with the cat8.Therefore, the physician decided to remove the cat8.Upon removal of the cat8, the physician found that the cat8 was fractured at the proximal length.Therefore, the sheath and the cat8 were removed from the patient together.The procedure was ended at this point and the physician plans to continue the procedure at a later date.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned cat8 confirmed that the catheter was fractured.Evaluation revealed signs of torquing at the fracture site.If the device is torqued against resistance during use, damage such as a fracture may occur.Based on the reported complaint, the patient¿s tortuous anatomy may have contributed to resistance during the procedure.Further evaluation revealed multiple ovalizations on the distal fractured segment, and evaluation of the non-penumbra sheath also revealed multiple ovalizations and scuff marks.The ovalizations on the cat8 aligns with the ovalizations non-penumbra sheath.This damage is likely incidental to the complaint and could have occurred while removing the distal fractured segment from the non-penumbra sheath.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.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 8
• 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: 20700726
• Report Number: 3005168196-2024-00387
• Device Sequence Number: 11701506
• Product Code: QEW
• UDI-Device Identifier: 00815948022324
• UDI-Public: 00815948022324
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K192833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2025

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: 09/27/2025
• Device Catalogue Number: CAT8XTORQ115KIT
• Device Lot Number: H00001220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 12/20/2024; Not provided
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 01/08/2025; 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2022
• 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: 77 YR
• Patient Sex: Female