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

Model Number PXSLIMLAN150T45

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 03/15/2021

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 internal iliac artery (iia) using pod packing coils (pod pcs) and a lantern delivery microcatheter (lantern).It should be noted that the patient's anatomy was tortuous and calcified.During the procedure, the physician successfully implanted one pod coil into the target location.Next, while attempting to advance a pod pc into the target vessel, the coil became stuck as it was exiting the distal tip of the lantern.The physician was unable to move the pod pc back and forth; therefore, the lantern containing the pod pc was removed from the patient.After removing the lantern, the physician discovered a kink approximately three to five centimeters from the distal tip.Therefore, neither the lantern nor the pod pc were used to continue the procedure.The procedure was completed using another pod pc and another lantern.There was no report of an adverse effect to the patient.

Event Description

The patient was undergoing a coil embolization procedure in the internal iliac artery (iia) using pod packing coils (pod pcs) and a lantern delivery microcatheter (lantern).It should be noted that the patient''s anatomy was tortuous and calcified.During the procedure, the physician successfully implanted one pod coil into the target location.Next, while attempting to advance a pod pc into the target vessel, the coil became stuck when a few centimeters of the coil was advanced out of the distal tip of the lantern.The physician was unable to move the pod pc back and forth; therefore, the lantern containing the pod pc was removed from the patient.After removing the lantern, the physician discovered a kink approximately three to five centimeters from the distal tip.Therefore, neither the lantern nor the pod pc were used to continue the procedure.The procedure was completed using another pod pc and another lantern.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned lantern confirmed kinks and revealed ovalizations on the distal shaft.If the device is forcefully manipulated against resistance, damage such as this may occur.This damage likely contributed to the inability to advance the coil during the procedure.Further evaluation revealed coagulated blood within the catheter¿s lumen.During functional testing, a stainless steel-mandrel was unable to be advanced through the lantern due to the coagulated blood, and the mandrel could not advance any further; therefore, no further testing could be performed.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.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11672660
• MDR Text Key: 245618702
• Report Number: 3005168196-2021-00761
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016689
• UDI-Public: 00814548016689
• Combination Product (y/n): Y
• PMA/PMN Number: K152840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2023
• Device Model Number: PXSLIMLAN150T45
• Device Catalogue Number: PXSLIMLAN150T45
• Device Lot Number: F99523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• 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: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1