MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 7; QEW

Catalog Number	LITNG7XTORQ130
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the iliac artery using an indigo system aspiration catheter 7 (cat7), a diagnostic catheter, and a guidewire.It should be reported that the patient''s anatomy was tortuous.During the procedure, the physician successfully completed one pass in the target location using the cat7.While advancing the cat7 during the second pass, the physician experienced resistance.The physician then noticed under fluoroscopy that the cat7 was fractured at the distal length.The fractured cat7 segment was retrieved from the patient using a snare device.The procedure was completed using a new cat7.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.
Additional Manufacturer Narrative
Evaluation of the returned cat7 confirmed a fracture on the distal shaft.If the device is advanced against resistance, damage such as a kink may occur.Subsequently, if the device is retracted against resistance, the kink may worsen to a fracture.The reported tortuous patient anatomy may have contributed to the resistance during advancement.Further evaluation revealed kinks along the cat7, and the distal tip was flattened.This damage was incidental to the complaint.The flattened distal tip was likely due to the distal tip being snared during removal.The kinks may have occurred during packaging for return to penumbra.Penumbra products are visually 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 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: 18968484
• Report Number: 3005168196-2024-00103
• Device Sequence Number: 6666173
• Product Code: QEW
• UDI-Device Identifier: 00815948022584
• UDI-Public: 815948022584
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K210083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/18/2026
• Device Catalogue Number: LITNG7XTORQ130
• Device Lot Number: H00003606
• 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: 02/27/2024
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005