MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM FLASH ASPIRATION CATHETER; QEW

Catalog Number	LITNGFHT100BER
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Unspecified Vascular Problem (4441)
Date of Event	09/05/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
The product was not returned for evaluation.Vessel perforation and death are included as possible complications in the instructions for use (ifu) for the indigo aspiration system.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right pulmonary artery using an indigo system flash aspiration catheter (flash catheter), indigo system lightning flash aspiration tubing (flash tubing).During the procedure, the physician made three passes and was able to successfully remove clot from the target vessel using the flash catheter.It was reported the patient¿s oxygen level increased from 65% to 85%.The flash catheter was removed to be flushed.While advancing the flash catheter back into the target location, the physician experienced resistance and torqued the flash catheter.The patient¿s health condition then declined.The physician performed an angiogram and noticed a perforation in the main pulmonary artery.It was reported that the patient later expired.The cause of death was the main pulmonary artery perforation.The cause of the perforation is unknown.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right pulmonary artery using an indigo system flash aspiration catheter (flash catheter) and a non-penumbra sheath.It was reported that although the patient arrived stable, the patient¿s health condition began to decline by the start of the procedure.It was reported that the non-penumbra sheath used in the procedure was stiff and was placed via jugular access.During the procedure, the physician made three passes and was able to successfully remove clot from the target vessel using the flash catheter.It was reported the patient¿s oxygen level increased from 65% to 85%.The flash catheter was removed to be flushed.The flash catheter was again advanced to the target location.The flash catheter was being torqued against resistance during use.The patient¿s condition declined further.Before removal of the devices, the physician performed an angiogram.It was reported that the angiogram was inconclusive but did not look normal.It was reported that the patient later expired due to the patient''s worsening condition.The relationship between the flash catheter and the patient¿s death is unknown.
Additional Manufacturer Narrative
The product was not returned for evaluation.Vascular complications and death are included as possible complications in the instructions for use (ifu) for the indigo aspiration system.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.

• Brand Name: INDIGO SYSTEM FLASH ASPIRATION CATHETER
• 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: 17857870
• Report Number: 3005168196-2023-00447
• Device Sequence Number: 14998263
• Product Code: QEW
• UDI-Device Identifier: 00815948024885
• UDI-Public: 815948024885
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K222358
• 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): 11/04/2023
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/20/2026
• Device Catalogue Number: LITNGFHT100BER
• Device Lot Number: F00006444
• 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: Not provided
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 11/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2023
• 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: Death
• Patient Age: 55 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005