MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT7 ASPIRATION CATHETER; QEW

Catalog Number	CAT7DKIT
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat a dialysis graft using an indigo system aspiration catheter 7 d (cat7 d) and an 8fr non-penumbra sheath.During the procedure, the physician advanced the cat7 d into the clot, torqued it through the graft, and completed two passes using the cat7 d.Next, the physician advanced the cat7 d with resistance to the target location and aspirated clot for the third pass.Subsequently, the cat7 d became clogged, and the physician removed it to flush.Upon flushing the cat7 d, saline was noticed to be leaking at the mid-shaft and the cat7 d was noticed to be bent at the mid-shaft.Therefore, the cat7 d was not used for the remainder of the procedure.The procedure was completed using a non-penumbra balloon catheter and the same sheath.There was no report of an adverse effect to the patient.
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.
Additional Manufacturer Narrative
Evaluation of the returned cat7d revealed that the catheter was kinked.This damage is likely the reported bend at the mid-shaft.If the cat7d is advanced against resistance during use, damage such as a kink may occur.Further evaluation revealed an additional kink and damage to the distal tip.This damage was incidental to the reported complaint and may have occurred during use.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.

• Brand Name: INDIGO SYSTEM CAT7 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: 14686376
• Report Number: 3005168196-2022-00289
• Device Sequence Number: 4711982
• Product Code: QEW
• UDI-Device Identifier: 00815948023970
• UDI-Public: 815948023970
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K193595
• 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): 07/13/2022
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/20/2025
• Device Catalogue Number: CAT7DKIT
• Device Lot Number: H12416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2022
• 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: 05/19/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 06/14/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2022
• 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: 50 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005