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

Catalog Number	SEP8
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/15/2019
Type of Reportable Event	Serious Injury
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 to treat an occluded arteriovenous (av) fistula graft using an indigo system separator 8 (sep8).During the procedure, the physician made several passes using the sep8 with an indigo system catd aspiration catheter (catd) and a sheath.While removing the sep8 after completion of the procedure, the physician noticed under fluoroscopy that the wire on the distal tip of the sep8 had broken off.The physician then attempted to aspirate the broken wire and capture it using a non-penumbra embolic protection device; however, it was unsuccessful.It was reported that the physician decided to leave the broken wire and believed there was no risk to the patient.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the returned sep8 core wire and wrapping wire was fractured distal to the bulb at approximately 149.0 cm from the proximal end.The fractured distal tip of the sep8 was left in the patient and, therefore, was not returned for evaluation.Conclusions: evaluation of the returned sep8 confirmed 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 and the device is continuing to be used, the wrapping wire may fatigue and fracture.The catd used in the procedure was not returned.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
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9452375
• Report Number: 3005168196-2019-02305
• Device Sequence Number: 2973304
• Product Code: QEW
• UDI-Device Identifier: 00814548017440
• UDI-Public: 00814548017440
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 11/15/2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/27/2022
• Device Catalogue Number: SEP8
• Device Lot Number: F90572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 12/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 01/01/2005