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	07/29/2024
Type of Reportable Event	Malfunction
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 short sheath, and a guidewire.During the procedure, the physician advanced the cat8 into the target vessel and successfully completed one pass.While removing the cat8, the physician experienced resistance and upon removal, the physician found that the distal end of the cat8 had fractured off.Therefore, the cat8 was removed using a snare device.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned cat8 revealed that the distal tip was damaged and the markerband was detached.The distal tip damage likely caused the markerband to detach from the catheter during the procedure.Based on the reported event, the root cause of the damage could not be determined.The markerband was not returned for evaluation.Further evaluation revealed kinks along the catheter shaft.This damage was incidental to the complaint, and likely occurred during packaging of the device for return.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.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 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: 20057681
• Report Number: 3005168196-2024-00288
• Device Sequence Number: 15362422
• Product Code: QEW
• UDI-Device Identifier: 00815948022324
• UDI-Public: 00815948022324
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K193244
• 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
• Report Date (Section B): 10/16/2024
• 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: 04/26/2025
• Device Catalogue Number: CAT8XTORQ115KIT
• Device Lot Number: H00000100
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2022
• 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: 65 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005