MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 3 ASPIRATION CATHETER; DXE

Model Number	CAT3-A
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Suction Failure (4039)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2020
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 in the posterior tibial artery using an indigo system cat3 aspiration catheter (cat3) and a non-penumbra sheath.During the procedure, the physician advanced the cat3 through the sheath, then initiated the aspiration; however, no aspiration was observed and the cat3 was therefore removed.Upon removal, it was noticed that the cat3 was kinked at the midshaft.The physician then flushed the cat3 and it separated in two pieces exposing the inner coiling.The procedure was completed using a new cat3 and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the cat3 was fractured approximately 57.0 cm from the hub and the support coil winds were exposed.The cat3 was ovalized approximately 131.0 cm from the hub.Conclusions: evaluation of the returned cat3 confirmed a fracture and the inner coil winds were exposed.Stress marks were observed near the fracture; this indicates that the device was likely kinked prior to fracturing.If cat3 is manipulated at an extreme angle during use, damage such as a kink and subsequent fracture may occur.Further evaluation of the returned cat3 revealed that the catheter was ovalized.This damage was likely incidental to the reported complaint.No other devices associated with the complaint were returned for evaluation.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 CAT 3 ASPIRATION CATHETER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9892120
• Report Number: 3005168196-2020-00456
• Device Sequence Number: 14058685
• Product Code: DXE
• UDI-Device Identifier: 00814548016085
• UDI-Public: 00814548016085
• Combination Product (Y/N): Y
• Initial Reporter Country: AU
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2020
• 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: 01/21/2022
• Device Model Number: CAT3-A
• Device Catalogue Number: CAT3
• Device Lot Number: F88079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005