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

Catalog Number	LITNG12HTORQ115
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	04/26/2022
Type of Reportable Event	Death
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left pulmonary artery using the lightning aspiration tubing (lightning), indigo system cat12 aspiration catheter (cat12), and non-penumbra sheath.During the procedure, the physician initially obtained access in the main pulmonary artery (mpa) using a 6f sheath and a diagnostic catheter.The physician then upsized to a second sheath and completed two passes using the cat12.Subsequently, while using the cat12 in the left pulmonary artery (lpa), the physician noticed a perforation.It was reported that the cat12 was not advanced past the lpa.The physician then performed multiple angiograms of the mpa and lpa; however, the location of the perforation could not be located.Consequently, the patient expired.It is unknown if the perforation or patient's death was related to the use of the cat12.
Additional Manufacturer Narrative
The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Potential adverse events in the labeling with the indigo aspiration system include, but are not limited to, vessel spasm, thrombosis, dissection or perforation, hematoma or hemorrhage at access site, inability to completely remove the thrombus, including death.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• 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: 14473821
• Report Number: 3005168196-2022-00225
• Device Sequence Number: 19982585
• Product Code: QEW
• UDI-Device Identifier: 00815948022577
• UDI-Public: 815948022577
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K202821
• 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): 05/20/2022
• 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: 02/03/2025
• Device Catalogue Number: LITNG12HTORQ115
• Device Lot Number: H12512
• 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: 04/26/2022
• Initial Report FDA Received Date: 05/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 86 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005