MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING BOLT 7; QEW

Catalog Number	LITNGBT7TQ130
Medical Device Problem Codes	Fracture (1260); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the popliteal and posterior tibial artery using an indigo system aspiration catheter 7 (cat7), indigo system lightning bolt aspiration tubing (lightning bolt aspiration tubing), and a non-penumbra sheath.During the procedure, the physician advanced the cat7 over the guidewire into the target location.It was reported that a previously placed stent in the superficial femoral artery (sfa) made it difficult to advance the cat7 into the distal area of the target location.The physician torqued the cat7 to redirect the distal end of the cat7 past the stent and noticed a kink at the proximal end of the cat7.The physician then tried to straighten out the kink when the cat7 fractured at the proximal end where the kink had occurred.Therefore, the cat7 was removed.The procedure was completed using a new cat7, same lightning bolt aspiration tubing, and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned cat7 confirmed a fracture on the proximal shaft and revealed signs of torquing at the fracture site.If the cat7 is torqued against resistance during advancement, damage such as a kink may occur and if the kink is further manipulated, the kink may worsen to a fracture.The resistance was likely due to the previously placed stent in the superficial femoral artery as mentioned in the complaint.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 LIGHTNING BOLT 7
• 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: 19294214
• Report Number: 3005168196-2024-00180
• Device Sequence Number: 20667488
• Product Code: QEW
• UDI-Device Identifier: 00815948025462
• UDI-Public: 815948025462
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/10/2024
• 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: H00004167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• 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: 04/14/2024
• Initial Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• 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: 68 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005