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

Model Number CAT8XTORQ115-A

Device Problems Material Deformation (2976); Suction Failure (4039)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the deep femoral vein using an indigo system aspiration catheter 8 (cat8) and a non-penumbra sheath.During the procedure, the cat8 did not aspirate and subsequently, the physician noticed the cat8 was flattened in two locations mid-shaft.It was unknown whether the damage occurred upon removal from the packaging or while attempting to aspirate.Therefore, the cat8 was no longer used.The procedure was completed using another cat8 and the same sheath.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned cat8 confirmed that the catheter was ovalized in the mid-shaft.If the device is forcefully gripped, pinched or otherwise mishandled during use, damage such as an ovalization may occur.Further evaluation revealed additional ovalizations throughout the catheter shaft.This damage was incidental to the reported complaint and may have occurred during packaging for return.During the functional test with a demonstration canister and pump max, the cat8 was able to aspirate water into the canister.Penumbra devices 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.H3 other text: placeholder.

• Brand Name: INDIGO SYSTEM ASPIRATION CATHETER 8
• Type of Device: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11497930
• MDR Text Key: 240317755
• Report Number: 3005168196-2021-00511
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00815948022478
• UDI-Public: 00815948022478
• Combination Product (y/n): Y
• PMA/PMN Number: K160533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,06/23/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2023
• Device Model Number: CAT8XTORQ115-A
• Device Catalogue Number: CAT8XTORQ115
• Device Lot Number: H10743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 03/16/2021
• Supplement Dates Manufacturer Received: 06/22/2021
• Supplement Dates FDA Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1