MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT 8 ASPIRATION CATHETER; DXE

Model Number	LITNG8XTORQ115-A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the cat8 was ovalized approximately 114.5 cm from the hub.Conclusions: evaluation of the returned cat8 confirmed a distal tip ovalization.If the cat8 is forcefully gripped or pinched during use, damage such as a distal ovalization may occur.This damage likely contributed to the reported no aspiration during the procedure.During functional testing, a slow aspiration was observed from the cat8 while attempted to aspirate water through the catheter.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat a deep vein thrombosis (dvt) in the inferior vena cava (ivc) using an indigo system aspiration catheter 8 (cat8) and a non-penumbra sheath.During the procedure, the physician advanced the cat8 through the sheath into the target location, then initiated aspiration.Halfway through the procedure, no aspiration was observed and subsequently, the physician decided to remove the cat8.Upon removal of the cat8, the physician noticed that the distal end of the cat8 was ovalized; therefore, it was not use for the remainder of the procedure.The procedure was completed using a new cat8 and the same sheath.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CAT 8 ASPIRATION CATHETER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10737630
• Report Number: 3005168196-2020-01818
• Device Sequence Number: 1767842
• Product Code: DXE
• UDI-Device Identifier: 00815948022546
• UDI-Public: 00815948022546
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K193244
• 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
• Report Date (Section B): 09/29/2020
• 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: 06/22/2023
• Device Model Number: LITNG8XTORQ115-A
• Device Catalogue Number: LITNG8XTORQ115
• Device Lot Number: H10567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• 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: 09/29/2020
• Initial Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Date Report Sent to FDA: 01/01/2005