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

Model Number PXSLIMLAN150T45

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/26/2020

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2020-01542.

Event Description

The patient was undergoing a coil embolization procedure in the ovarian vein using lantern delivery microcatheters (lantern) and pod packing coils (podj).During the procedure, while attempting to rotate the lantern from the left renal vein into the left ovarian vein, the lantern broke approximately fifteen centimeters from the hub.Therefore, the lantern was pulled out.The physician then placed three ruby coils and two podjs into the target vessel using a new lantern.Next, the physician advanced another podj into the target vessel and determined that it was too long; therefore, the physician decided to remove the podj.While retracting the podj, it became stuck at the distal end of the lantern and subsequently, unintentionally detached within the lantern.Therefore, the lantern containing the detached podj was removed and the podj was flushed out.The procedure was completed using a new podj and the same lantern.There was no report of an adverse effect to the patient.

Event Description

The patient was undergoing a coil embolization procedure in the ovarian vein using a lantern delivery microcatheters (lantern) and pod packing coils (podj).During the procedure, while attempting to rotate the lantern from the left renal vein into the left ovarian vein, the lantern broke approximately fifteen centimeters from the proximal hub outside the patient''s body.Therefore, the lantern was pulled out.The physician then placed three ruby coils and two podjs into the target vessel using a new lantern.Next, the physician advanced another podj into the target vessel and determined that it was too long; therefore, the physician decided to remove the podj.While retracting the podj, it became stuck at the distal end of the lantern and subsequently, unintentionally detached within the lantern.Therefore, the lantern containing the detached podj was removed and the podj was flushed out.The procedure was completed using a new podj and the same lantern.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #1 mfr report: 3005168196-2020-01541.Section b.Box 5.Describe event or problem.Results: the lantern was fractured approximately 21.5 cm from the hub.Conclusions: evaluation of the returned lantern confirmed proximal shaft fracture.If the device is forcefully manipulated at extreme angles during use, damage such as a kink and subsequent fracture may occur.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: 3005168196-2020-01542.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10560518
• MDR Text Key: 208815022
• Report Number: 3005168196-2020-01541
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2023
• Device Model Number: PXSLIMLAN150T45
• Device Catalogue Number: PXSLIMLAN150T45
• Device Lot Number: F96738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• 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: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1