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

Model Number	SEP12-A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemoptysis (1887); Cough (4457)
Date of Event	10/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right and left pulmonary arteries using an indigo system cat12 aspiration catheter (cat12) and an indigo system separator 12 (sep12).During the procedure, the physician performed thrombectomy in the right pulmonary artery using the cat12.The physician then completed three passes in the left pulmonary artery.Subsequently, while performing aspiration during the next pass, the patient started coughing and experienced hemoptysis.Therefore, the cat12 was removed.It was reported that the physician did not experience resistance while using the cat12 and sep12.It was also reported that there was no noticeable damage to the cat12 or sep12.The procedure ended at this point and the patient was intubated and was taken for a computed tomography (ct) scan.
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 number: 3005168196-2021-02601.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and is being corrected on this follow-up # 01 mfr report:.1.Section h.Box 6.Conclusion code 1 2.Section h.Box 10./11.Narrative/corrected data please note that the following section was inadvertently missed on the initial mfr report and is being included on this follow-up # 01 mfr report.1.Section h.Box 6.Conclusion code 2 the product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Hemoptysis is included as a possible complication in the instructions for use (ifu) for an indigo aspiration system.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: 3005168196-2021-02601 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: 12835917
• Report Number: 3005168196-2021-02602
• Device Sequence Number: 4435006
• Product Code: QEW
• UDI-Device Identifier: 00815948021556
• UDI-Public: 00815948021556
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K202821
• 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): 09/23/2022
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/29/2023
• Device Model Number: SEP12-A
• Device Catalogue Number: SEP12
• Device Lot Number: F102988
• 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: 10/22/2021
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2020
• 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: 56 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005