MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 7; QEW

Model Number	CAT7DKIT-A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left iliac artery using an indigo system aspiration catheter 7 (cat7).During the procedure, the rotating hemostasis valve (rhv) broke when tightening it and was unable to form a seal.Therefore, the rhv was removed.The procedure was completed by placing the tubing directly on the back of the cat7 to finish the last pass, and a new rhv was not used.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned rhv could not confirm the reported inability to form a seal.During functional testing, the rhv valve rotor cup was fastened and unfasted without an issue and was able to seal and unseal the rhv without an issue.The rhv was flushed with a syringe and no leaking was observed.Penumbra catheters 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.H3 other text : placeholder.
Event or Problem Description
On (b)(6) 2021, the patient was undergoing a thrombectomy procedure in the left iliac artery using an indigo system aspiration catheter 7 (cat7).During the procedure, the rotating hemostasis valve (rhv) broke when tightening it and was unable to form a seal.Therefore, the rhv was removed.The procedure was completed by placing the tubing directly on the back of the cat7 to finish the last pass, and a new rhv was not used.It was reported that distal embolization was noted after aspiration with the cat7.There were no reported complications during the procedure.The patient was given ia rtpa, and a balloon angioplasty performed.This event was resolved the next day on (b)(6) 2021.The patient had improved from baseline.The peripheral/ distal embolization was reported to be a non-serious adverse event with a definite relationship to the cat7 and the index procedure.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information received: 1.Section b.Box 5.Describe event or problem.This report is associated with mfr report number: 3005168196-2021-01294 h3 other text : placeholder.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 7
• Common Device Name: QEW
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11784815
• Report Number: 3005168196-2021-00972
• Device Sequence Number: 17055488
• Product Code: QEW
• UDI-Device Identifier: 00815948023970
• UDI-Public: 00815948023970
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K193595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2021
• 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: 01/19/2024
• Device Model Number: CAT7DKIT-A
• Device Catalogue Number: CAT7DKIT
• Device Lot Number: C25027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 05/12/2021; 01/14/2005
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 06/09/2021; 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Date Report Sent to FDA: 01/01/2005