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

Catalog Number	LITNG7XTORQ130
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
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.This report is associated with mfr report number: 3005168196-2022-00501.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the femeral artery using an indigo system aspiration catheter 7 (cat7) and a non-penumbra sheath.During the procedure, the physician advanced the cat7 into the sheath and began aspiration.Next, when the physician removed the cat7, it was noticed to be fractured at the proximal end at the sheath hub.Subsequently, the physician removed the cat7.It was reported that a second cat7 also fractured at the proximal end at the sheath hub.The procedure was completed with an indigo system aspiration catheter 6 (cat6) and tpa.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the femoral artery using an indigo system aspiration catheter 7 (cat7) and a non-penumbra sheath.During the procedure, the physician advanced the cat7 into the sheath and began aspiration.Next, when the physician removed the cat7, it was noticed to be fractured at the proximal end at the sheath hub.Subsequently, the physician removed the cat7.It was reported that a second cat7 also fractured at the sheath hub.The procedure was completed with an indigo system aspiration catheter 6 (cat6) and tpa.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: section b.Box 5.Describe event or problem.Evaluation of the returned cat7 confirmed that the device was fractured.Based on the reported event, this fracture was likely the result of a kink at the hub of the sheath outside of the patient and subsequent torqueing.If the cat7 manipulated at an angle outside of the parent catheter, the device may become kinked.If the kinked device is subsequently torqued against resistance, the device may fracture.Further evaluation of the device revealed a kink on the catheter shaft.This damage was likely incidental to the complaint.Evaluation of the returned cat7 confirmed that the device was fractured.Based on the reported event, this fracture was likely the result of a kink at the hub of the sheath outside of the patient and subsequent torqueing.If the cat7 manipulated at an angle outside of the parent catheter, the device may become kinked.If the kinked device is subsequently torqued against resistance, the device may fracture.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.This report is associated with mfr report number: 3005168196-2022-00501.

• 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: 15686584
• Report Number: 3005168196-2022-00500
• Device Sequence Number: 6801860
• Product Code: QEW
• UDI-Device Identifier: 00815948022584
• UDI-Public: 815948022584
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 12/21/2022
• 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: 04/27/2025
• Device Catalogue Number: LITNG7XTORQ130
• Device Lot Number: H00000125
• 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: 10/04/2022
• Supplement Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2022
• 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: 40 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005