MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 7; QEW

Catalog Number	LITNGBT7TQ130
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned cat7 confirmed the catheter was fractured and was stuck inside the non-penumbra sheath.If the device is retracted against resistance, damage such as a fracture may occur.The proximal fractured cat7 segment was not returned for evaluation, and the returned segment was unable to be removed from the non-penumbra sheath during evaluation.Further evaluation revealed kinks and an ovalization on the non-penumbra sheath.The root cause of this damage could not be determined; however, this damage may have contributed to resistance during the procedure.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 iliac artery using an indigo system aspiration catheter 7 (cat7), a non-penumbra sheath, and a guidewire.It was reported that the patient had peripheral artery disease (pad).During the procedure, the physician completed two passes using the cat7.After completion of the procedure, the physician experienced resistance while removing the cat7 from the sheath and noticed that the cat7 fractured at the midshaft.The physician removed the proximal portion of the cat7.Fluoroscopic imaging revealed the remaining fractured portion of the cat7 was inside of the sheath.The sheath containing the fractured portion of the cat7 was removed.The procedure was completed at this point.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 7
• 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: 20761014
• Report Number: 3005168196-2024-00390
• Device Sequence Number: 21155155
• Product Code: QEW
• UDI-Device Identifier: 00815948025462
• UDI-Public: 00815948025462
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K223186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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 Catalogue Number: LITNGBT7TQ130
• Device Lot Number: H00005274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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: 64 YR
• Patient Sex: Male