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

Catalog Number	SEP8
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
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.H3 other text: placeholder.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat deep vein thrombosis (dvt) in the left popliteal to iliac vein using an indigo system separator 8 (sep8), an indigo system aspiration catheter 8 (cat8), and non-penumbra sheaths.During the procedure, the physician experienced resistance while advancing the sep8 and while retracting the sep8 during the first pass.Subsequently, the physician observed under fluoroscopy that the wire distal to the bulb of the sep8 had fractured in the left femo-iliac vein.The cat8 was advanced toward the sep8 wire in an attempt to aspirate the wire, without success.The physician decided to leave the sep8 wire in the patient and did not make a plan to remove it.The procedure was completed using the same cat8 and the same sheaths.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned sep8 confirmed that the device was fractured distal to the bulb.The complaint indicated that resistance was experienced during advancement and retraction of the device during the procedure.If the sep8 is manipulated against resistance, damage such as a kink and subsequent fracture may occur.The root cause of resistance during the procedure could not be determined.Penumbra catheters 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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 17971138
• Report Number: 3005168196-2023-00468
• Device Sequence Number: 4958666
• Product Code: QEW
• UDI-Device Identifier: 00815948022980
• UDI-Public: 815948022980
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K161523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2024
• 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: 01/10/2026
• Device Catalogue Number: SEP8
• Device Lot Number: H00001872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005