MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12; QEW

Catalog Number	LITNG12HTORQ100
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2022
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the main pulmonary artery, right pulmonary artery, left pulmonary artery, left interlobar, lingual artery and right lower lobar using an indigo system aspiration catheter 12 (cat12), a non-penumbra guide sheath and a guidewire.During the procedure, the physician completed eight to nine passes in the target vessel using the cat12.While attempting the final pass and when torquing the cat12, the physician encountered resistance and noticed under fluoroscopy that the cat12 was kinked.Subsequently, the cat12 fractured approximately 3 inches from the distal end of the catheter.The physician then re-advanced the guidewire through the cat12, inflated a 4mm balloon at the fracture location to provide support.The cat12 with the inflated balloon was pulled back into the guide sheath.Subsequently, the cat12 along with the inflated balloon and the guide sheath were removed from the patient.The procedure ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
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: 3005168196-2022-00387 1.Section g.Box 3.Report source.Evaluation of the returned cat12 confirmed that the device was fractured on the distal shaft.The complaint indicated that the cat12 was kinked prior to fracture.If the device is torqued against resistance during use damage such as a kink and a subsequent fracture may occur.The root cause of the resistance could not be determined.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 12
• 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: 15263724
• Report Number: 3005168196-2022-00387
• Device Sequence Number: 17768308
• Product Code: QEW
• UDI-Device Identifier: 00815948022553
• UDI-Public: 815948022553
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K210323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2022
• 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: 09/28/2024
• Device Catalogue Number: LITNG12HTORQ100
• Device Lot Number: H11874
• 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: 07/27/2022
• Supplement Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2021
• 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: 64 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005