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	04/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned cat7 could not confirm the reported rhv fracture.Evaluation revealed that the catheter was fractured near the hub.This damage is likely the reported fracture.If the proximal end of the cat7 is manipulated against resistance during use, damage such as a kink and subsequent fracture may occur.Based on the reported event, the reported damage was noticed after completing a successful pass.Further evaluation revealed bends and kinks throughout the length of the catheter, and the distal tip was damaged.This damage was likely incidental to the complaint and may have occurred during packaging for return to penumbra.Penumbra products 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 popliteal artery using an indigo system aspiration catheter 7 (cat7).During the procedure, after completing the first pass, the physician noticed that the aspiration had decreased.Upon inspection, the cat7 was found to be broken at the hub.Therefore, the cat7 was removed.The procedure was completed using a balloon angioplasty.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: 17005264
• Report Number: 3005168196-2023-00245
• Device Sequence Number: 12550548
• Product Code: QEW
• UDI-Device Identifier: 00815948022584
• UDI-Public: 815948022584
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 05/25/2023
• 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: 07/14/2025
• Device Catalogue Number: LITNG7XTORQ130
• Device Lot Number: H00000702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• 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: 05/03/2023
• Initial Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2022
• 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
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005