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

Model Number	SEP8-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2020
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, iliac and femoral veins using an indigo system separator 8 (sep8) and indigo system aspiration catheter 8 (cat8).During the procedure, the physician completed multiple passes using the sep8 and cat8.Afterwards, the physician noticed under fluoroscopy that the wire distal to the bulb of the sep8 broke off.Therefore, the broken sep8 distal wire was aspirated out using the cat8.The procedure was completed using a new sep8 and the same cat8.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the atraumatic tip distal to the bulb was fractured off and not returned for evaluation.Conclusions: evaluation of the returned sep8 confirmed that the atraumatic tip distal to the bulb was fractured.It was reported that multiple passes were completed using the device.If the device is repeatedly manipulated against tough clot burden, the core wire and wrapping wire may fatigue.Subsequently, the atraumatic tip may fracture if the device continues to be used.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: 10818097
• Report Number: 3005168196-2020-01951
• Device Sequence Number: 13731731
• Product Code: QEW
• UDI-Device Identifier: 00814548017440
• UDI-Public: 00814548017440
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K161523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2020
• 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: 01/23/2023
• Device Model Number: SEP8-A
• Device Catalogue Number: SEP8
• Device Lot Number: F95774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Date Report Sent to FDA: 01/01/2005