MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT3 ASPIRATION CATHETER; DXE

Model Number	CAT3KIT-A
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2020
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 posterior and anterior tibial arteries using an indigo system aspiration catheter 3 (cat3) and a non-penumbra sheath.During the procedure, the physician encountered resistance while introducing the cat3 into the sheath.Subsequently, the cat3 broke near the proximal end, outside of the patient's body.Therefore, the cat3 was removed.The procedure was completed using another catheter and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the cat3 was fractured approximately 15.0 cm from the hub.The cat3 was ovalized approximately 113.0, 139.0, and 149.5 cm from the hub.Conclusions: evaluation of the returned cat3 confirmed a fracture in the proximal shaft.Stress marks were observed near the fracture; this indicates that the fracture was likely kinked prior to fracturing.If the 3maxc is forcefully advance against resistance, damage such as a kink may occur.Further manipulation of a kinked device may result in a fracture.Further evaluation of the returned cat3 revealed ovalization along the catheter shaft.These ovalizations were likely incidental to the reported complaint.Penumbra catheters are visually 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 CAT3 ASPIRATION CATHETER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10279997
• Report Number: 3005168196-2020-00939
• Device Sequence Number: 14117192
• Product Code: DXE
• UDI-Device Identifier: 00815948020535
• UDI-Public: 00815948020535
• Combination Product (Y/N): Y
• Initial Reporter State: IL
• 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): 06/21/2020
• 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: 09/23/2022
• Device Model Number: CAT3KIT-A
• Device Catalogue Number: CAT3KIT
• Device Lot Number: F93253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/21/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 07/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Date Report Sent to FDA: 01/01/2005