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

Model Number	SEP8-A
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The patient was undergoing a thrombectomy procedure in the inferior vena cava (ivc) using an indigo system separator 8 (sep8) and an indigo system aspiration catheter 12 (cat12).During the procedure, the physician made multiple passes with the devices in an attempt to clear extensive deep vein thrombosis (dvt).Subsequently, the sep8 was withdrawn in order to flush clot from the cat12.Upon removal, the physician noticed that the distal tip of the sep8 was stretched proximal to the bulb.Therefore, the sep8 was no longer used.The procedure was completed using a new sep8 and the same cat12.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the core wire was fractured, and the wrapping wire was unraveled approximately 150.0 cm from the proximal end.Conclusions: evaluation of the returned sep8 revealed that the atraumatic tip distal to the bulb was fractured.If the sep8 is repeatedly manipulated through tough clot burden, damage such as this may occur.If the core wire fractures, the wrapping wire will unravel.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 8
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10656533
• Report Number: 3005168196-2020-01679
• Device Sequence Number: 3552685
• Product Code: QEW
• UDI-Device Identifier: 00814548017440
• UDI-Public: 00814548017440
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K161523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2020
• Report Date (Section F): 01/01/2005

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: Health Professional
• Device Expiration Date: 07/05/2021
• Device Model Number: SEP8-A
• Device Catalogue Number: SEP8
• Device Lot Number: C21821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Date Report Sent to FDA: 01/01/2005