MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 7D; 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	12/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left brachial artery using an indigo system separator 7d (sep7d), an indigo system aspiration catheter 7d (cat7d), indigo system separator 7 (sep7), an indigo system aspiration catheter 7 (cat7) and a non-penumbra sheath.During the procedure, the physician made one pass using the cat7d and sep7d.While making the second pass, the physician kinked the proximal end of the cat7d, but the physician decided to continue to use the kinked cat7d.Next, upon completing the third pass, the physician was removing the sep7d; however, resistance was encountered and the wire at the distal bulb of the sep7d broke off within the vessel.Subsequently, the physician was experiencing resistance while removing the cat7d and broke it into two separate pieces at the proximal end where the kink had occurred.Therefore, the cat7d was not used for the remainder of the procedure.It was also reported that the physician determined it was safe to leave the broken wire of the sep7d in the vessel and decided to place a stent to cover the broken wire into the vessel wall.The procedure was completed using a new cat7, lightning, and a new sep7.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, an investigation cannot be performed.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 1.3005168196-2023-00005.

• Brand Name: INDIGO SYSTEM SEPARATOR 7D
• 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: 16099682
• Report Number: 3005168196-2023-00004
• Device Sequence Number: 14999042
• Product Code: QEW
• UDI-Device Identifier: 00815948023994
• UDI-Public: 815948023994
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K193595
• 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): 01/04/2023
• 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: 09/21/2025
• Device Catalogue Number: SEP7D
• Device Lot Number: H00001188
• 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: 12/07/2022
• Initial Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2022
• 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: 55 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005