MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 6; DXE

Model Number CAT6KIT-A

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012); Suction Failure (4039)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2020

Event Type  malfunction  

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.This report is associated with mfr report number: 3005168196-2020-00917.

Event Description

The patient was undergoing a thrombectomy procedure in the right subclavian and axillary vein using an indigo system aspiration catheter 6 (cat6), indigo system separator 6 (sep6) and, a non-penumbra sheath.It was reported that the patient was brought back after a round of infusion and the physician wanted to utilize the existing access and did not want to upsize existing sheath in the right upper arm.It was also noted that the access to the lesion was tortuous.During the procedure, the physician made multiple passes using the cat6 and sep6.While attempting to make another pass, the hospital technician experienced resistance while advancing and retracting the sep6.After some time, the physician noticed that there was no flow in the aspiration tubing; therefore, the cat6 and sep6 were removed as a unit.Upon removal, it was noticed that the cat6 was ovalized around the distal end.The physician then removed the sep6 from the cat6 and noticed that the distal bulb of the sep6 was missing.The cat6 was subsequently flushed and the broken distal bulb of the sep6 was ejected from the cat6.The procedure was completed using a balloon catheter and balloon angioplasty.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the cat6 was ovalized approximately 129.0, 131.0, and 134.5 cm from the hub.Conclusions: evaluation of the returned cat6 confirmed that the distal shaft of the catheter was ovalized.If the cat6 is forcefully manipulated against resistance during use, damage such as ovalization may occur.The tortuous lesion may have contributed to the reported resistance.Evaluation of the returned sep6 revealed that the bulb was fractured off the delivery wire.If the sep6 is forcefully manipulated against resistance, damage such as this may occur.The root cause of resistance was likely the ovalization in the cat6.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra separators 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.This report is associated with mfr report number: 1.3005168196-2020-00917.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 6
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10256663
• MDR Text Key: 198299199
• Report Number: 3005168196-2020-00916
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00815948020405
• UDI-Public: 00815948020405
• Combination Product (y/n): Y
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,06/17/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2023
• Device Model Number: CAT6KIT-A
• Device Catalogue Number: CAT6KIT
• Device Lot Number: F96349
• 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 07/24/2020
• Supplement Dates FDA Received: 08/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR