MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 3; DXE

Catalog Number	SEP3
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2018-00198.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the anterior and posterior tibial arteries using an indigo system separator 3 (sep3).During the procedure, after using the sep3 with an indigo system cat3 aspiration catheter (cat3), the physician removed the sep3 to clean the device.The physician then wanted to remove the torque device from the sep3 in order to insert the sep3 back through the disposable sheath and into the cat3; however, the torque device would not come off of the sep3.Therefore, the sep3 was not reinserted into the cat3 and a new sep3 was opened.However, the physician encountered the same issue when trying to remove the torque device from the second sep3.At this point, the physician was able to remove part of the thrombus and decided to remove the cat3.The patient was then placed on tissue plasminogen activator (tpa) over night.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device in complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device is no longer available for return.Therefore, 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.The device is not available for return.

• Brand Name: INDIGO SYSTEM SEPARATOR 3
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7208421
• Report Number: 3005168196-2018-00197
• Device Sequence Number: 1173501
• Product Code: DXE
• UDI-Device Identifier: 00814548013312
• UDI-Public: 00814548013312
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2017

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
• Operator of Device: Physician
• Device Expiration Date: 08/02/2018
• Device Catalogue Number: SEP3
• Device Lot Number: F65163
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 01/19/2018
• Supplement Report FDA Received Date: 03/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR