MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 8; DXE

Model Number	CAT8XTORQ115KIT-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the pulmonary arteries using an indigo system aspiration catheter 8 (cat8), penumbra engine (engine), penumbra engine canister (canister), non-penumbra adapter.It was reported that the patient had a pulmonary embolism with significant right ventricular strain.During the procedure, while aspirating in the right pulmonary artery using the cat8, the physician noticed that the cat8 was aspirating a lot of air with minimal blood.The system was then checked for air leaks.The adapter was tightened, the lid on the canister was tightened, and the canister was properly seated on the engine.The placement of the cat8 was not occlusive, and blood was visualized to be leaking out from the junction between the hub of the cat8 and the cat8 itself.Subsequently, a tegaderm was placed over the area of the leak, and the physician continued aspiration using the cat8 until a staff member came into the room with another cat8.The procedure was completed using another cat8.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the cat8 was fractured distal to the hub.Conclusions: evaluation of the returned cat8 revealed a fracture near the hub.If the device is forcefully manipulated at extreme angles during use, damage such as this may occur.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.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 8
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10286467
• Report Number: 3005168196-2020-00948
• Device Sequence Number: 689629
• Product Code: DXE
• UDI-Device Identifier: 00815948020450
• UDI-Public: 00815948020450
• Combination Product (Y/N): Y
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2020
• 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: 10/08/2022
• Device Model Number: CAT8XTORQ115KIT-A
• Device Catalogue Number: CAT8XTORQ115KIT
• Device Lot Number: H10090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/23/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Date Report Sent to FDA: 01/01/2005