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

Catalog Number SEP8

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2019

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.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.

Event Description

The patient was undergoing a venacaval thrombectomy procedure using an indigo system separator 8 (sep8).During the procedure, the tip of the sep8 distal to the separator "bead" fractured and lodged into the inferior vena cava (ivc) wall of fibrotic clot along the wall.The "bead" was still attached to the sep8 and it was embedded into what appeared to be old fibrous clot/tissue.The cause of this could possibly be that the cat8 was being maneuvered forward into the target location and it pinched the tip of the wire against the vessel wall and the fibrous clot as the physician was pulling back on the sep8.The procedure was successfully completed by using a new sep8.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following section was inadvertently missed on the initial mfr report and is being updated on this follow-up # 01 mfr report: 3005168196-2019-01478.Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2019-01478.Please note that this complaint was submitted to the fda by the user facility with the following reference number: (b)(4).

Event Description

The patient was undergoing a thrombectomy procedure in the inferior vena cava (ivc) using an indigo system separator 8 (sep8).During the procedure, the wire tip distal to the sep8 bulb broke off and lodged into the wall of fibrotic clot in the target vessel.The physician made a decision to leave the wire tip in the clot and remove the sep8 from the procedure.The procedure was then completed using 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
• MDR Report Key: 8847324
• MDR Text Key: 152914644
• Report Number: 3005168196-2019-01478
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548017440
• UDI-Public: 00814548017440
• Combination Product (y/n): Y
• PMA/PMN Number: K161523
• 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: 01/01/2005,07/02/2019

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: 07/18/2021
• Device Catalogue Number: SEP8
• Device Lot Number: F84730
• Was Device Available for Evaluation?: No
• 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: 07/02/2019
• Initial Date FDA Received: 07/31/2019
• Supplement Dates Manufacturer Received: 08/16/2019
• Supplement Dates FDA Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR