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

Model Number	CAT8TORQ85KIT-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2020
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat a femoral deep vein thrombosis (dvt) using an indigo system aspiration catheter 8 (cat8).During the procedure, while performing the coring technique in the target vessel using the cat8, the physician heard a hissing sound.Subsequently, the physician noticed that the cat8 was broken at the hub; therefore, the cat8 was removed.The procedure was completed using a new cat8.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat a femoral deep vein thrombosis (dvt) using an indigo system aspiration catheter 8 (cat8) and non-penumbra sheath.During the procedure, the physician completed approximately three to five passes in the target vessel using the cat8.While attempting to make another pass using the cat8, the physician heard a hissing sound while performing a coring technique.Subsequently, the physician noticed the cat8 was broken at the hub; therefore, it was removed.The procedure was completed using a new cat8 and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra representative on (b)(6) 2020: 1.Section b.Box 5.Describe event or problem results: the cat8 was fractured approximately 2.0 cm from the hub.The device was ovalized approximately 32.0 and 85.5 cm from the hub.Conclusions: evaluation of the returned cat8 confirmed a fracture near the hub.If the device is forcefully manipulated at extreme angles during use, damage such as a kink and subsequent fracture may occur.Further evaluation revealed ovalizations on the mid-shaft and near the distal tip.This damage was likely incidental to the reported complaint.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.H3 other text : placeholder.

• 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: 10517653
• Report Number: 3005168196-2020-01425
• Device Sequence Number: 14337253
• Product Code: DXE
• UDI-Device Identifier: 00815948020412
• UDI-Public: 00815948020412
• 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): 08/19/2020
• 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: 06/24/2022
• Device Model Number: CAT8TORQ85KIT-A
• Device Catalogue Number: CAT8TORQ85KIT
• Device Lot Number: F91266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Date Report Sent to FDA: 01/01/2005