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

Catalog Number SEP8

Device Problem Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2019

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.

Event Description

The patient was undergoing a thrombectomy procedure in the femoral vein using an indigo system separator 8 (sep8).During the procedure, the physician used an indigo system aspiration catheter 8 (cat8) with the sep8 for about 20 minutes.The sep8 was then removed to clean out the cat8 because the aspiration had slowed down.As the physician removed the sep8 from the cat8, it was noticed that the tip of the sep8, distal of the bulb, was unraveled.Therefore, the procedure was completed using a new sep8 and the same cat8.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the indigo system separator 8 (sep8) core wire was fractured distal to the bulb approximately 149.5 cm from the proximal end.The wrapping wire winds distal to the bulb were stretched.The total length of the device was approximately 154.0 cm.Conclusions: evaluation of the returned sep8 confirmed the wrapping wire distal to the bulb was stretched and the core wire was fractured.If the device is manipulated repeatedly through tough clot burden, damage such as a fractured core wire may occur.If the core wire is fractured and the device is subsequently manipulated through clot burden or retracted from the patient, the wrapping wire will likely stretch.Penumbra separators are 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.

• Brand Name: INDIGO SYSTEM SEPARATOR 8
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8297157
• MDR Text Key: 134741101
• Report Number: 3005168196-2019-00173
• 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: 01/01/2005,01/04/2019

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: 08/14/2021
• Device Catalogue Number: SEP8
• Device Lot Number: F85219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• 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: 01/04/2019
• Initial Date FDA Received: 02/01/2019
• Supplement Dates Manufacturer Received: 03/12/2019
• Supplement Dates FDA Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR