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

Model Number PXSLIMLAN135STR

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 08/26/2021

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.

Event Description

The patient was undergoing a coil embolization procedure in the superior mesenteric artery using a lantern delivery microcatheter (lantern), a guide catheter and a guidewire.During the procedure, the physician successfully implanted ten coils in the target vessel using the lantern.Subsequently, the physician removed the lantern from the patient to reposition the guide catheter.Upon reinserting the lantern into the patient, the physician noticed a pin hole leak on the distal end of the lantern.Therefore, the lantern was removed.It was reported that the physician was slightly rough with the lantern.The procedure was completed using another lantern and the same guide catheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned lantern revealed a fracture on the proximal shaft.If the device is manipulated against resistance or is mishandled at extreme angles during use, damage such as a kink and subsequent fracture may occur.This damage may be the reported pin hole leak as there was no hole observed on the distal end of the catheter.Further evaluation revealed a kink on the proximal shaft and an ovalization on the distal shaft.This damage may be incidental to the reported 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.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: 12478540
• MDR Text Key: 271660139
• Report Number: 3005168196-2021-02061
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016641
• UDI-Public: 00814548016641
• 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: 01/01/2005,10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PXSLIMLAN135STR
• Device Catalogue Number: PXSLIMLAN135STR
• Device Lot Number: F106861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• 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: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR