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

Catalog Number	LITNG12XTORQ100
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat a deep vein thrombosis (dvt) using an indigo system cat12 aspiration catheter (cat12), a non-penumbra sheath and a guidewire.During the procedure, the physician gained right common femoral access using the cat12 and the sheath.Subsequently, after completing 2-3 passes, while advancing the cat12 into the popliteal vessel of the left leg, the physician encountered resistance and noticed a kink on the cat12 under fluoroscopy.Therefore, the physician decided to retract the cat12.While retracting the cat12, the cat12 broke into two pieces at mid-shaft.The physician then used a snare device and removed the remaining part of the cat12 from the patient's body.The procedure was completed using a new cat12 and a new non-penumbra sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned cat12 confirmed the device was fractured.Evaluation also revealed kinks at and between the two fractures on the catheter.This indicates the catheter fracture was likely the result of a kink.If the device is forcefully manipulated against resistance, the device may become kinked.Further manipulation of a kinked device against resistance may cause the catheter to subsequently fracture.Evaluation revealed an additional fracture.This break was likely incidental and may have occurred during the snaring process.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: 16401000
• Report Number: 3005168196-2023-00081
• Device Sequence Number: 5605744
• Product Code: QEW
• UDI-Device Identifier: 00815948022560
• UDI-Public: 815948022560
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K210323
• 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): 02/17/2023
• 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: 07/11/2025
• Device Catalogue Number: LITNG12XTORQ100
• Device Lot Number: H00000683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2023
• 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: 01/26/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2022
• 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: 61 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005