MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 12 ASPIRATION CATHETER; QEW

Catalog Number	LITNG12HTORQ115
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	06/13/2022
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.
Event or Problem Description
On (b)(6) 2022, the patient underwent a thrombectomy procedure using an indigo system aspiration catheter 12 (cat12).It was reported the patient had previous intervention on the affected limb, and there were no reported complications during the procedure.The post-treatment angiogram showed a significant amount of residual thrombus requiring secondary intervention.The retained thrombus was reported to be a serious adverse event with a possible relationship to the cat12 and the index procedure.
Event or Problem Description
On (b)(6) 2022, the patient underwent a thrombectomy procedure using an indigo system aspiration catheter 12 (cat12).It was reported the patient had previous intervention on the affected limb, and there were no reported complications during the procedure.The post-treatment angiogram showed a significant amount of residual pulmonary thrombosis requiring secondary intervention.The residual pulmonary thrombosis was reported to be a serious adverse event with a possible relationship to the cat12 and the index procedure.On 30-jul-22, additional information received indicated that the residual pulmonary thrombosis was unrelated to the cat12 and the index procedure.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 07/30/2022: 1.Section b.Box 5.Describe event or problem.Please note that the device associated with this complaint was expected to be returned; however, the device was not returned to the manufacturer.Therefore, 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.Note: the residual pulmonary thrombosis was previously adjudicated to be a serious adverse event with a possible relationship to the index procedure and a possible relationship to the cat 12.However, on (b)(6) 2022, it was adjudicated that the residual pulmonary thrombosis is unrelated to the cat 12.Therefore, this event is not considered reportable against the cat12.H3 other text : placeholder.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the follow-up #01 mfr report and is being included on this follow-up #02 mfr report: 1.Section h.Box 4.Device manufacture date h3 other text : placeholder.

• Brand Name: INDIGO SYSTEM CAT 12 ASPIRATION CATHETER
• 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: 14963131
• Report Number: 3005168196-2022-00330
• Device Sequence Number: 5389514
• Product Code: QEW
• UDI-Device Identifier: 00815948022577
• UDI-Public: 815948022577
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K202821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2022
• 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: 07/06/2024
• Device Catalogue Number: LITNG12HTORQ115
• Device Lot Number: H11541
• 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: 06/13/2022
• Supplement Date Received by Manufacturer: 07/30/2022; 01/14/2005
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 08/26/2022; 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005