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

Catalog Number	CAT8TORQ85KIT
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 right superficial femoral artery (sfa) using an indigo system aspiration catheter 8 (cat8), an indigo system separator 8 (sep8), a guiding sheath, a stent, and a guidewire.During the procedure, the physician advanced the cat8 and sep8 into the target vessel using the guiding sheath and initiated aspiration.It was reported that the physician experienced resistance while advancing the cat8 into the guiding sheath.The cat8 was then torqued to perform aspiration over a wide area.After pulling on the hub of the cat8 approximately 2-3 centimeters, the physician noticed under fluoroscopy that the distal part of the cat8 did not move.Under fluoroscopy the physician checked the iliac bifurcation and found that the mid-shaft of the cat8 had fractured at the bifurcation.The physician then used a balloon catheter to hold the cat8 and sep8 in place inside of the guiding sheath to remove the devices together.The physician also attempted to insert the guidewire for additional support, but the guidewire would not enter the fractured section of the cat8.While removing, the physician cut another segment of the cat8 using scissors.The procedure was completed using a non-penumbra catheter, and a new guiding sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Corrected data: 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:3005168196-2024-00010 1.Section h.Box 6.Evaluation codes: device code 1 & device code 2 additional info: evaluation of the returned cat8 revealed a fracture on the proximal end and revealed signs of torquing at the fracture site.If the cat8 is over-torqued against resistance, damage such as a fracture may occur.Further evaluation also confirmed that the cat8 was cut.Based on the reported event, this cut was done outside the patient during removal of the device.A demonstration cat8 was advanced through the returned non-penumbra guiding sheath without an issue.The root cause of resistance during the procedure could not be determined.Penumbra devices 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.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by the penumbra clinical team: 1.Section a.Box 4.Weight 2.Section b.Box 5.Describe event or problem.Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up mfr report #2: 1.Section a.Box 2.Age at time of event.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right superficial femoral artery (sfa) using an indigo system aspiration catheter 8 (cat8), an indigo system separator 8 (sep8), a guiding sheath, and a guidewire.It was reported that thrombectomy was being performed to remove the thrombus within a previously placed stent in the right sfa.During the procedure, the physician advanced the cat8 and sep8 into the target vessel using the guiding sheath and initiated aspiration.It was reported that the physician experienced resistance while advancing the cat8 into the guiding sheath.The cat8 was then torqued to perform aspiration over a wide area.After pulling on the hub of the cat8 approximately 2-3 centimeters, the physician noticed under fluoroscopy that the distal part of the cat8 did not move.Under fluoroscopy the physician checked the iliac bifurcation and found that the mid-shaft of the cat8 had fractured at the bifurcation.The physician then used a balloon catheter to hold the cat8 and sep8 in place inside of the guiding sheath to remove the devices together.The physician also attempted to insert the guidewire for additional support, but the guidewire would not enter the fractured section of the cat8.While removing, the physician cut another segment of the cat8 using scissors.The procedure was completed using a non-penumbra catheter, and a new guiding sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was updated on this follow up mdr: 1.Section h.Box 11.Additional manufacturer narrative.Device evaluation: evaluation of the returned cat8 revealed a fracture on the proximal end and revealed signs of torquing at the fracture site.If the cat8 is over-torqued against resistance, damage such as a fracture may occur.Further evaluation also confirmed that the cat8 was cut.Based on the reported event, this cut was done outside the patient during removal of the device.A demonstration cat8 was advanced through the returned non-penumbra guiding sheath without an issue.Based on the reported event, the previously placed stent within the anatomy may have contributed to resistance during the procedure.Penumbra devices 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: 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: 18466129
• Report Number: 3005168196-2024-00010
• Device Sequence Number: 14224839
• Product Code: QEW
• UDI-Device Identifier: 00815948022294
• UDI-Public: 815948022294
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/30/2025
• 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: 05/03/2026
• Device Catalogue Number: CAT8TORQ85KIT
• Device Lot Number: H00002749
• 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: 12/14/2023
• Supplement Date Received by Manufacturer: 01/19/2024; 08/08/2025; 09/16/2025
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 02/13/2024; 09/07/2025; 09/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 41 KG
• Date Report Sent to FDA: 01/01/2005