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	02/08/2023
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 superficial femoral artery (sfa) using an indigo system catheter 7 (cat7), a non-penumbra sheath and a guidewire.During the procedure, the physician successfully completed two passes.Next, the physician removed the cat7 to perform an angiogram.The physician then attempted to advance the cat7 through the sheath to complete the third pass, and subsequently, the proximal end of the cat7 broke outside of the patient.Therefore, the cat7 was removed.The procedure was completed using an indigo system catheter 8 (cat8) and a new non-penumbra sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Please note that this complaint was submitted to the fda by the user facility with the following reference number: mw5114881.The following sections are being updated based on additional information included in the user facility report submitted to the fda: 1.Section g.Box 3.Report source h3 other text : placeholder.

• 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: 16588456
• Report Number: 3005168196-2023-00121
• Device Sequence Number: 12236124
• Product Code: QEW
• UDI-Device Identifier: 00815948022584
• UDI-Public: 815948022584
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2023
• 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: 05/16/2025
• Device Catalogue Number: LITNG7XTORQ130
• Device Lot Number: H00000279
• Was Device Available for Evaluation?: No
• 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: 02/21/2023
• Supplement Date Received by Manufacturer: 05/16/2023; 02/21/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 05/23/2023; 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2022
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005