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

Catalog Number	LITNG7XTORQ130
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2022
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.Device placeholder.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa) and popliteal artery using a lightning aspiration tubing (lightning), indigo system aspiration catheter 7 (cat7), indigo system separator 7 (sep7), and a non-penumbra sheath.During the procedure, the physician made approximately two to three passes using the cat7 and sep7.Subsequently, the physician used the dilator to open the cat7 back up and then attempted to load the sep7 into the cat7; however, the cat7 broke at the hub.Therefore, the cat7 was removed the procedure was completed using an indigo system aspiration catheter 6 (cat6) and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The following section is being updated based on additional information provided by a penumbra sales representative on 01/24/2023: section b.Box 5.Describe event or problem.Evaluation of the returned cat7 confirmed that the catheter was fractured.If the cat7 is manipulated forcefully or at an angle during use, damage such as a kink and subsequent fracture may occur.Based on the reported event, the device was pinched too hard by the physician during use.Further evaluation revealed bends throughout the length of the catheter shaft.This damage was incidental to the reported complaint and likely occurred during packaging for return to penumbra.Due to the returned damage the cat7 was unable to be functionally tested.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the superficial femoral artery (sfa) and popliteal artery using a lightning aspiration tubing (lightning), indigo system aspiration catheter 7 (cat7), indigo system separator 7 (sep7), and a non-penumbra sheath.During the procedure, the physician made approximately two to three passes using the cat7 and sep7.Subsequently, the physician used the dilator to open the cat7 back up and then attempted to load the sep7 into the cat7; however, the physician pinched the cat7 too hard and broke it at the hub.Therefore, the cat7 was removed.The procedure was completed using an indigo system aspiration catheter 6 (cat6) and the same sheath.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM LIGHTNING 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: 16268941
• Report Number: 3005168196-2023-00051
• Device Sequence Number: 6474874
• Product Code: QEW
• UDI-Device Identifier: 00815948022584
• UDI-Public: 815948022584
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K210083
• 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,Followup
• Report Date (Section B): 03/06/2023
• 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: 06/27/2025
• Device Catalogue Number: LITNG7XTORQ130
• Device Lot Number: H00000605
• 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: 01/02/2023
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2022
• 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: 70 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005