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

Model Number	CAT8XTORQ115KIT-B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.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 femoropopliteal using an indigo system aspiration catheter 8 (cat8), non-penumbra 5fr diagnostic catheter, and non-penumbra sheath.It was also reported that the sheath was previously buckling into the aorta while using a diagnostic catheter and guidewire to cross the lesion.During the procedure, the cat8 was advanced over the guidewire and retracted back once with aspiration.Next, the physician advanced the cat8 more distally and then removed the guidewire; subsequently, the physician wanted to retract the cat8 without the guidewire.However, while retracting, the midshaft of the cat8 become broken inside of the sheath at the bifurcation.The physician attempted to remove the broken cat8 using a snare device and a balloon catheter but was unsuccessful.Therefore, the patient was taken to surgery to remove the remaining broken cat8.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned cat8 confirmed a fracture on its mid-shaft.Evaluation also revealed that the catheter was twisted at the fractured location.Based on the reported event, this is likely due to the sheath prolapsing into the aorta at the bifurcation.If the cat8 is retracted against resistance while pinned within anatomy, the device may become fractured.Further evaluation of the device also revealed kinks and an ovalization on the distal fractured portion.This damage was likely incidental to the complaint and may have occurred during multiple retrieval attempts.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: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11467544
• Report Number: 3005168196-2021-00486
• Device Sequence Number: 4041509
• Product Code: DXE
• UDI-Device Identifier: 00815948022485
• UDI-Public: 00815948022485
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2021
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2023
• Device Model Number: CAT8XTORQ115KIT-B
• Device Catalogue Number: CAT8XTORQ115KIT
• Device Lot Number: H10536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Date Report Sent to FDA: 01/01/2005