MAUDE Adverse Event Report: PENUMBRA, INC. LANTERN DELIVERY MICROCATHETER; DQY

Model Number PXSLIMLAN135T45

Device Problems Break (1069); Physical Resistance/Sticking (4012)

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

Event Date 04/29/2021

Event Type  malfunction  

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.This report is associated with mfr report number: 3005168196-2021-01165.

Event Description

The patient was undergoing a coil embolization procedure in the internal iliac artery using a lantern delivery microcatheter (lantern), ruby coils, and a non-penumbra angled glide catheter (4fr 100cm).During the procedure, the lantern broke in half around the midshaft to the distal end while being retracted.It was reported a ruby coil was stuck in the broken lantern.Therefore, the lantern was removed by pulling the ruby coil.The procedure was completed using a new lantern and new pod coil.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned lantern confirmed a midshaft fracture.If the lantern is forcefully manipulated at extreme angles during use, the device may become kinked.Subsequently retracting the kinked device may result in the device fracture.Further evaluation of the device revealed an additional fracture and kinks in the catheter.This damage was likely incidental to the complaint and may have occurred during packaging for return to penumbra.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.This report is associated with mfr report number: 1.3005168196-2021-01165, h3 other text : placeholder.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11891320
• MDR Text Key: 253174521
• Report Number: 3005168196-2021-01164
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016658
• UDI-Public: 00814548016658
• Combination Product (y/n): Y
• PMA/PMN Number: K152840
• 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: 01/01/2005,07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2023
• Device Model Number: PXSLIMLAN135T45
• Device Catalogue Number: PXSLIMLAN135T45
• Device Lot Number: F101513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1