MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 12 ASPIRATION CATHETER; QEW

Catalog Number	LITNG12HTORQ100
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned cat12 confirmed that the catheter was fractured.If the cat12 is advanced against resistance, damage such as a kink may occur.Subsequently, if a kinked device further manipulated against resistance, the kink may worsen to a fracture.Further evaluation revealed an additional fracture.This damage was incidental to the reported complaint and the root cause could not be determined.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the superior femoral vein (sfv) using a lightning aspiration tubing (lightning), an indigo system aspiration catheter 12 (cat12), a non-penumbra sheath, and a guidewire.During the procedure, the physician placed the sheath at the target location and advanced the guidewire through the sheath.Then, the physician advanced the cat12 through the sheath over the guidewire.The guidewire was removed, and the physician successfully completed two passes using the cat12.Next, while attempting to complete a third pass, the physician noticed that the cat12 was kinked at the midshaft under fluoroscopy.The physician began to straighten out the cat12 by pulling back the cat12.While pulling back the cat12, the physician experienced resistance and noticed that the cat12 was breaking apart.Next, the physician was able to pull the cat12 back into the sheath and removed the cat12 and the sheath together.It was reported that the cat12 was removed intact.The procedure was completed at this point.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CAT 12 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: 17243956
• Report Number: 3005168196-2023-00313
• Device Sequence Number: 6698332
• Product Code: QEW
• UDI-Device Identifier: 00815948022553
• UDI-Public: 815948022553
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K210323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2023
• 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: 08/29/2025
• Device Catalogue Number: LITNG12HTORQ100
• Device Lot Number: H00001039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2023
• 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: 06/05/2023
• Initial Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• 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: 35 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005