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

Model Number	SEP8-B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2021-02019, 3005168196-2021-02020, 3005168196-2021-02021.
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.
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.1.Section b.Box 5.Describe event or problem evaluation of the two returned 10f rhvs revealed that one was returned fully intact while the other was returned disassembled.Evaluation of the disassembled 10f rhv revealed the device was returned with its rotor cap disconnected, its shim was out, and the rubber seal was not present.If the rotor cap is over rotated when opening, damage such as this may occur.The 10f rhv could not be properly reassembled; therefore, functional testing could not be performed.Due to the return condition, the reported complaint could not be confirmed, and the root cause could not be determined.Evaluation of the fully assembled 10f rhv could not confirm the reported complaint.Evaluation revealed an undamaged, functional device.During functional testing, a demonstration sep12 was advanced and retracted through the 10f rhv without issue.Evaluation of the returned sep8 confirmed that the atraumatic tip distal to the bulb was fractured.If the device is repeatedly manipulated through tough clot burden, the core wire and wrapping wire may become damaged.If the device continues to be used, it may fracture.Penumbra accessories and 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.This report is associated with mfr report numbers: 1.3005168196-2021-02019.2.3005168196-2021-02020.3.3005168196-2021-02021.H3 other text : placeholder.
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.

• 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: 12457855
• Report Number: 3005168196-2021-02022
• Device Sequence Number: 4739405
• Product Code: QEW
• UDI-Device Identifier: 00815948022980
• UDI-Public: 00815948022980
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K161523
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2023
• Device Model Number: SEP8-B
• Device Catalogue Number: SEP8
• Device Lot Number: F102075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• 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: 10/15/2021
• Initial Report FDA Received Date: 09/12/2021
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005