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

Model Number CAT8XTORQ115KIT-S

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2021

Event Type  Injury  

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 Description

The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa) using an indigo system aspiration catheter 8 (cat8), a non-penumbra sheath, and a guidewire.It should be noted that the patient had a steep iliac bifurcation.During the procedure, the physician completed one pass using the cat8 and the sheath.The physician then placed multiple stents from the popliteal artery to the sfa.While advancing the cat8 through the stents for the second pass, the cat8 became stuck on a stent strut.Subsequently, the physician torqued the cat8, and the cat8 broke into two pieces.Therefore, the physician removed part of the cat8 and the sheath.Next, the physician attempted to retrieve the broken distal end of the cat8 using two snare devices; however, the attempts were unsuccessful.The physician then attempted to use a balloon catheter to push the broken piece of the cat8 into the aorta to grab it; however, it was also unsuccessful.Therefore, an open surgery via cutdown technique was performed to remove the broken piece of the cat8.The procedure ended after the surgery.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned cat8 confirmed that the catheter was fractured.Based on the damage at the fracture, this break was likely due to the torquing of the device.The catheter being stuck on a stent may have contributed to the damage.Further evaluation revealed multiple kinks and ovalization on the fractured distal segment.This damage was incidental to the reported complaint and may have occurred during removal from the patient or post-procedure.Penumbra catheters are visually 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
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12016843
• MDR Text Key: 256738727
• Report Number: 3005168196-2021-01355
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00815948022324
• UDI-Public: 00815948022324
• Combination Product (y/n): Y
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,06/17/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2023
• Device Model Number: CAT8XTORQ115KIT-S
• Device Catalogue Number: CAT8XTORQ115KIT
• Device Lot Number: H10826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 06/17/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR