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

Catalog Number SEP6

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2019

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 to treat a femoral popliteal lesion using an indigo system separator 6 (sep6).During the procedure, the physician advanced the sep6 through an indigo system aspiration catheter 6 (cat6).The physician then began retracting and advancing the sep6 within the cat6.However, while making a pass with the sep6, the tip of the sep6 became dislodged within the cat6.The physician decided to end the procedure and remove the sep6 and cat6 together from the patient.No additional information is available.

Manufacturer Narrative

Results: the (b)(6) distal tip was bent, had offset wrapping coil winds, and the bulb was missing.Conclusions: evaluation of the returned (b)(6) confirmed the bulb was missing on the distal tip.If the device is repeatedly manipulated through tough clot burden, the distal tip may fatigue.If the fatigued device is continuously manipulated, the tip may become damaged such that the bulb detaches from the wire.During functional testing, the returned (b)(6) and a demonstration (b)(6) were advanced and retracted through the returned cat6 without issue.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.H3 other text : placeholder.

• Brand Name: INDIGO SYSTEM SEPARATOR 6
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8664275
• MDR Text Key: 146847912
• Report Number: 3005168196-2019-01079
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016146
• UDI-Public: 00814548016146
• Combination Product (y/n): Y
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,05/05/2019

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: 04/13/2020
• Device Catalogue Number: SEP6
• Device Lot Number: F75661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• 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: 05/05/2019
• Initial Date FDA Received: 06/03/2019
• Supplement Dates Manufacturer Received: 07/30/2019
• Supplement Dates FDA Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR