MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 8; QEW

Model Number	LITNG8XTORQ115-A
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
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 left popliteal artery and left posterior tibial artery using an indigo system aspiration catheter 8 (cat8) and non-penumbra sheath.During the procedure, the physician was advancing the cat8 through the popliteal artery and experienced resistance at the posterior tibial artery.The physician stopped and as they were pulling the cat8 out of the sheath, they noticed the cat8 had ovalized at the mid-segment.The physician believed the cat8 had bent at a steep curve as the cat8 was pulled through the sheath.The procedure was completed by using a new cat8 and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Correction: please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report: 3005168196-2021-00705.Additional information: please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was disposed of and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: INDIGO SYSTEM LIGHTNING 8
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11631896
• Report Number: 3005168196-2021-00705
• Device Sequence Number: 14291962
• Product Code: QEW
• UDI-Device Identifier: 00815948022546
• UDI-Public: 00815948022546
• Combination Product (Y/N): Y
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K200771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2021
• 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: 08/11/2023
• Device Model Number: LITNG8XTORQ115-A
• Device Catalogue Number: LITNG8XTORQ115
• Device Lot Number: H10690
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Date Report Sent to FDA: 01/01/2005