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

Catalog Number	CAT3
Medical Device Problem Codes	Break (1069); Physical Resistance (2578); Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Results: the cat3 was fractured approximately 105.0 cm from the hub and the support coil winds were unraveled.The marker band was not present on the distal tip of the catheter shaft.A 3.0 cm piece of non-penumbra device was returned.Conclusions: evaluation of the returned cat3 confirmed that the device was fractured.If the device was forcefully retracted against resistance, damage such as a fracture may occur.The resistance that was experienced during the procedure may have occurred as a result of the kinked non-penumbra sheath and tortuous anatomy.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat an arterial vascular disease using an indigo system cat3 aspiration catheter (cat3).It was noted that the patient's anatomy was extremely tortuous.During the procedure, while advancing a cat3 through a non-penumbra sheath, the physician experienced resistance and removed the cat3.It was reported that the sheath was kinked causing the cat3 to get stuck and break at the transition point.Therefore, the physician used a snare device to successfully remove the broken cat3 piece from the patient.The patient was placed on lysis (thrombolytic) for another day because the disease was chronic in nature and minimal clot was removed with the cat3.There was no report of an adverse effect to the patient.

• 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: 7642467
• Report Number: 3005168196-2018-01258
• Device Sequence Number: 13898554
• Product Code: DXE
• UDI-Device Identifier: 00814548016085
• UDI-Public: 00814548016085
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/30/2018

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: Physician
• Device Expiration Date: 02/22/2021
• Device Catalogue Number: CAT3
• Device Lot Number: F82045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention