MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 8; DXE

Catalog Number SEP8

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

The product was disposed of by the hospital and is no longer available for return.Without the return of the device, the root cause of the problem cannot be determined.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 numbers: 3005168196-2017-01655.The hospital disposed of the device.

Event Description

The patient was undergoing a thrombectomy procedure using an indigo system aspiration catheter 8 (cat8) and an indigo system separator 8 (sep8).During the procedure, the physician removed the cat8 and sep8 from the patient's body to place a balloon in the patient's vein.The hospital technician then accidentally dropped the cat8 on the floor and therefore, the cat8 was not used to complete the procedure.Additionally, a portion of the sep8 touched the trash and therefore, the sep8 was not used to complete the procedure.The procedure was completed using a new cat8 and a new sep8.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM SEPARATOR 8
• 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: 6893944
• MDR Text Key: 87877936
• Report Number: 3005168196-2017-01656
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548017440
• UDI-Public: 00814548017440
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161523
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2017

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: Physician
• Device Expiration Date: 03/27/2020
• Device Catalogue Number: SEP8
• Device Lot Number: F75226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2017
• 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: 45 YR