MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM LIGHTNING 12; QEW

Catalog Number	LITNG12XTORQ100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemoptysis (1887)
Date of Event	05/03/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.Potential adverse events in the labeling with the penumbra system include, but are not limited to, hematoma or hemorrhage at the site, inability to completely remove thrombus, intracranial hemorrhage, ischemia, peripheral thromboembolic events, including death.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.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: 3005168196-2022-00247.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the pulmonary artery using the lightning aspiration tubing (lightning), indigo system cat12 aspiration catheter (cat12), indigo system separator 12 (sep12), and guidewire (amplatz).During the procedure, the physician accessed the left lower lobe using the guidewire and then advanced the cat12 over the guidewire.Next, the physician made three passes using the sep12 and noticed there was no flow back through the cat12.The physician then decided to retract the sep12 all the back to the rotating hemostasis valve (rhv) and re-advanced the sep12 to the distal end of the cat12.Subsequently, while advancing and retracting the sep12, the physician pulled back the cat12 and the patient started coughing up blood.Therefore, the sep12 and cat12 were removed.The physician ended the procedure at this point.The patient was then intubated, and the physician performed a bronchoscopy the same day that revealed blood in the lungs.It was also reported that three days later, a follow up pulmonary angiogram was performed that revealed little clot in the left lobe and showed no negative outcome to the pulmonary artery.All clots were removed from the lungs and the patient was extubated.The relationship between the coughing of the blood to cat12 and sep12 is unknown.

• Brand Name: INDIGO SYSTEM LIGHTNING 12
• 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: 14565884
• Report Number: 3005168196-2022-00246
• Device Sequence Number: 17663525
• Product Code: QEW
• UDI-Device Identifier: 00815948022560
• UDI-Public: 815948022560
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K210323
• 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): 06/01/2022
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/18/2024
• Device Catalogue Number: LITNG12XTORQ100
• Device Lot Number: H11715
• 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: 05/05/2022
• Initial Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• 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: Other
• Patient Age: 73 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005