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

Catalog Number	LITNGFHT115BER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the pulmonary artery using an indigo system flash aspiration catheter (flash catheter), a non-penumbra sheath, and a guidewire.During the procedure, the physician successfully used the flash catheter to remove clot in the target vessel.After completing another pass in a different branch of the pulmonary artery, the physician was torquing the flash catheter and noticed that it was fractured under fluoroscopy.Therefore, the flash catheter was removed.While handling the flash catheter after removal from the patient, the physician inadvertently kinked the flash catheter in multiple locations below the fracture.The procedure was successfully completed 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
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2023-00319.1.Section b.Box 5.Describe event or problem: evaluation of the returned flash catheter confirmed a fracture on the distal end and multiple kinks along the length of the device.It was reported that the fracture was observed under fluoroscopy while torquing the device.If the device is torqued against resistance, damage such as a kink and subsequent fracture may occur.Based on the reported complaint, the root cause of resistance could not be determined.The kinks on the device were incidental and was reported to have occurred after removal from the patient and during packaging 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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the pulmonary artery using an indigo system flash aspiration catheter (flash catheter), a non-penumbra sheath, and a guidewire.During the procedure, the physician successfully used the flash catheter to remove clot in the target vessel.After completing another pass in a different branch of the pulmonary artery, the physician was torqueing the flash catheter and noticed that it appeared fractured under fluoroscopy.The flash catheter was able to be retracted and removed intact.While handling the flash catheter after removal from the patient, the physician inadvertently kinked the flash catheter in multiple locations below the fracture.The procedure was successfully completed at this point.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM FLASH ASPIRATION CATHETER
• 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: 17261311
• Report Number: 3005168196-2023-00319
• Device Sequence Number: 20824776
• Product Code: QEW
• UDI-Device Identifier: 00815948024892
• UDI-Public: 815948024892
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K222358
• 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): 08/17/2023
• 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: 01/22/2026
• Device Catalogue Number: LITNGFHT115BER
• Device Lot Number: F00005083
• 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: 06/06/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• 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: 35 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005