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

Catalog Number	CAT8XTORQ115KIT
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the cat8 was kinked and ovalized approximately 110.0 -114.0 cm from the hub.Conclusions: evaluation of the returned cat8 revealed that the distal shaft was kinked and ovalized.If the cat8 is forcefully manipulated during use, damage such as kinks and ovalizations may occur.During the functional test, a demonstration sep8 was unable to advance through the returned cat8 due to the distal shaft damage.The sep8 and non-penumbra sheath identified in the complaint was not returned for evaluation.Penumbra catheters are visually 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 in the right and left femoral vein using an indigo system aspiration catheter 8 (cat8).During the procedure, after making four passes using the cat8 with an indigo system separator 8 (sep8) and a non-penumbra sheath, the physician removed the cat8 and the hospital technician found it to be kinked in four different places at the distal tip.However, the physician continued to use the same cat8 and sep8 to make another pass and completed the procedure.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 8
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9200084
• Report Number: 3005168196-2019-01936
• Device Sequence Number: 3058055
• Product Code: DXE
• UDI-Device Identifier: 00815948020450
• UDI-Public: 00815948020450
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K142870
• 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): 09/17/2019
• 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: 05/30/2022
• Device Catalogue Number: CAT8XTORQ115KIT
• Device Lot Number: F90669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• 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: 09/17/2019
• Initial Report FDA Received Date: 10/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Date Report Sent to FDA: 01/01/2005