MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 12; QEW

Model Number	SEP12-A
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
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.This report is associated with mfr report numbers: 3005168196-2021-02019, 3005168196-2021-02020, 3005168196-2021-02022.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the pulmonary arteries using an indigo system cat12 aspiration catheter (cat12), an indigo system separator 12 (sep12), and a rotating hemostasis valve (rhv).During the procedure, the physician was able to insert the sep12 through the rhv on the first attempt; however, upon removing the sep12 and attempting to reinsert it through the rhv again, the sep12 would not go into the rhv.Subsequently, the physician removed and replaced the rhv with a new rhv from another lightning kit; however, when attempting to insert the sep12 through the rhv, the same issue occurred.Therefore, the rhv and sep12 were removed.Next, the physician opened a new lightning 8 kit to obtain a smaller rhv and completed one pass using the smaller rhv and an indigo system separator 8 (sep8).While using the sep8 during the second pass, the physician noticed that the wire distal to the bulb of the sep8 had broken off in the right pulmonary artery.Therefore, the physician used a snare device to remove the broken sep8.The procedure was completed using a new sep8 and the same cat12 from the first lightning kit.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the pulmonary arteries using an indigo system cat12 aspiration catheter (cat12), an indigo system separator 12 (sep12), and a rotating hemostasis valve (rhv).During the procedure, the physician was able to insert the sep12 through the rhv on the first attempt; however, upon removing the sep12 and attempting to reinsert it through the rhv again, the sep12 would not go into the rhv.Subsequently, the physician removed and replaced the rhv with a new rhv from another lightning kit; however, when attempting to insert the sep12 through the rhv, the same issue occurred.Therefore, the rhv and sep12 were removed.Next, the physician completed one pass using a new smaller rhv and an indigo system separator 8 (sep8).While using the sep8 during the second pass, the physician noticed that the wire distal to the bulb of the sep8 had broken off in the right pulmonary artery.Therefore, the physician used a snare device to remove the broken sep8.The procedure was completed using a new sep8 and the same cat12 from the first lightning kit.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 3005168196-2021-02021.1.Section b.Box 5.Describe event or problem this report is associated with mfr report numbers: 1.3005168196-2021-02019; 2.3005168196-2021-02020; 3.3005168196-2021-02022; h3 other text : placeholder.

• Brand Name: INDIGO SYSTEM SEPARATOR 12
• 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: 12457856
• Report Number: 3005168196-2021-02021
• Device Sequence Number: 14637503
• Product Code: QEW
• UDI-Device Identifier: 00815948021556
• UDI-Public: 00815948021556
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K192981
• 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,Followup
• Report Date (Section B): 11/10/2021
• 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: 02/22/2024
• Device Model Number: SEP12-A
• Device Catalogue Number: SEP12
• Device Lot Number: F104012
• 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: 08/16/2021
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 09/12/2021
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2021
• 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: 54 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005