MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT7 ASPIRATION CATHETER; 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	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa) using an indigo system aspiration catheter 7 (cat7), an indigo system lightning bolt aspiration tubing (lightning bolt aspiration tubing), a non-penumbra sheath, and guidewires (0.035 and 0.014).It was reported that the patient had persistent peripheral vascular disease (pvd), a previously placed stent, and a bypass graft.During the procedure, the physician completed three to four passes using the cat7 and lightning bolt aspiration tubing.While advancing the cat7 over the 0.035 guidewire through the sheath and the stent, the physician experienced resistance and noticed that the cat7 was stuck.The 0.035 guidewire was then exchanged for the 0.014 guidewire.It is unknown whether the cat7 was stuck within the stent.The physician then noticed that the cat7 appeared to be fractured at the distal end under fluoroscopy.While removing the cat7, the physician experienced resistance and noticed that the cat7 was also twisted near the fracture at the distal end.The physician then used a snare device to remove the fractured part of the cat7.The patient was placed on tissue plasminogen activator (tpa) drip using a thrombolysis catheter.The procedure was completed the next day using another cat7, another lightning bolt aspiration tubing, and another sheath (7f).There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned cat7 confirmed a fracture at the mid-shaft, and the distal shaft was twisted.Evaluation revealed that the distal fractured segment was inside a non-penumbra sheath, and the non-penumbra sheath was fractured in multiple locations and its coil winds were wrapped around the distal fractured cat7 segment.If the device is torqued against resistance, damage such as a fracture may occur.It was mentioned in the reported event that the cat7 likely got stuck within the previous placed stent, during attempts to remove the catheter.This 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.

• Brand Name: INDIGO SYSTEM CAT7 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: 19843314
• Report Number: 3005168196-2024-00261
• Device Sequence Number: 6647831
• Product Code: QEW
• UDI-Device Identifier: 00815948025462
• UDI-Public: 00815948025462
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K223186
• 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): 07/26/2024
• 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 Catalogue Number: LITNGBT7TQ130
• Device Lot Number: H00004535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2024
• 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: 07/01/2024
• Initial Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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: 49 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005