MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 7; QEW

Catalog Number	SEP7D
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the basilic vein graft using an indigo system separator 7 (sep7), an indigo system aspiration catheter 7 (cat7), and a non-penumbra sheath.During the procedure, the physician made multiple passes using the sep7 and cat7.Subsequently, after making the final pass, the sep7 was stuck, and the physician noticed the wire at the distal bulb of the sep7 had broken off in the thrombosed fistula under fluoroscopy.Therefore, the physician attempted to use the cat7 to aspirate the broke wire of the sep7; however, the broken wire was stuck in the heavy thrombus and could not be removed.It was reported that the physician decided to leave the broken wire and believed there was no risk to the patient.The procedure had ended at this point and the physician placed a non-penumbra catheter for the patient to receive dialysis.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The product was not returned for evaluation.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.

• Brand Name: INDIGO SYSTEM SEPARATOR 7
• 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: 16117954
• Report Number: 3005168196-2023-00003
• Device Sequence Number: 5753829
• Product Code: QEW
• UDI-Device Identifier: 00815948023994
• UDI-Public: 815948023994
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K210083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2023
• 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: 02/10/2023
• Device Catalogue Number: SEP7D
• Device Lot Number: C24783
• Was Device Available for Evaluation?: No
• 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: 12/14/2022
• Initial Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2020
• 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 Age: 69 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005