MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 5; DXE

Model Number SEP5-A

Device Problem Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned cat5 confirmed that the distal shaft had multiple kinks.If the device is forcefully advanced against resistance, damage such as this may occur.This damage likely contributed to the reported the sep5 being unable to advance through the cat5 during the procedure.During functional testing, the returned sep5 was unable to be advanced through the cat5 due to the kinks in the cat5 distal shaft.Further evaluation of the device revealed an ovalization in its distal shaft.This damage is likely a result of forcefully gripped or pinched during use.Evaluation of the returned sep5 revealed that the pusher wire was kinked.If the device is advanced against resistance, damage such as this may occur.The resistance was likely contributed by the kinks in the cat5 catheter.Penumbra catheter and separators are inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2021-00698.

Event Description

The patient was undergoing a thrombectomy procedure to treat an arteriovenous (av) fistula in the right arm using an indigo system cat5 aspiration catheter (cat5), an indigo system separator 5 (sep5), a 5f sheath, and a guidewire.During the procedure, the physician accessed the fistula with the sheath and advanced the cat5 over the guidewire and past the thrombus.Subsequently, the physician pulled the cat5 back into the clot and decided to use the sep5.However, the sep5 would not advance to the end of the cat5.Therefore, the whole system was removed, and it was found that the distal end of the cat5 was bent and kinked.The procedure was completed using an indigo system catd aspiration catheter (catd).There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM SEPARATOR 5
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 11623617
• MDR Text Key: 244214764
• Report Number: 3005168196-2021-00699
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016108
• UDI-Public: 00814548016108
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SEP5-A
• Device Catalogue Number: SEP5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 91 YR