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

Model Number PXSLIMLAN150T45

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 09/27/2021

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 coil embolization procedure in the splenic artery using a lantern delivery microcatheter (lantern), ruby coils, non-penumbra coils, and a non-penumbra catheter.It should be noted that the patient¿s anatomy was mildly tortuous, narrowed and moderately calcified.During the procedure, while advancing a ruby coil as the first coil in the mid-shaft of the lantern, the physician experienced resistance.Subsequently, the physician retracted and removed the ruby coil and flushed the lantern.While re-advancing the ruby coil through the same lantern, the physician experienced resistance again.Therefore, the lantern was removed.The physician then successfully implanted the ruby coil in the target vessel using another lantern.The procedure was completed using two non-penumbra coils and the second lantern.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned lantern revealed an undamaged, functional device.During testing, a demonstration ruby coil was advanced through the lantern without an issue.The root cause of resistance during the procedure could not be determined.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
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 12692955
• MDR Text Key: 278435188
• Report Number: 3005168196-2021-02379
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016689
• UDI-Public: 00814548016689
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K152840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,11/22/2021

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: 02/18/2022
• Device Model Number: PXSLIMLAN150T45
• Device Catalogue Number: PXSLIMLAN150T45
• Device Lot Number: F88588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: Yes
• 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: 10/01/2021
• Initial Date FDA Received: 10/25/2021
• Supplement Dates Manufacturer Received: 11/08/2021
• Supplement Dates FDA Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Female