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

Catalog Number	PXSLIMLAN150STR
Medical Device Problem Codes	Fracture (1260); Leak/Splash (1354); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in two branches of the perfunda artery using lantern delivery microcatheters (lantern), a ruby coil, a pod packing coil (pod pc), and a guidewire.It was reported that the patient¿s anatomy was tortuous.During the procedure, while attempting to advance a lantern to the target location, the physician experienced resistance.The physician then noticed the lantern to be fractured and blood leaking near the hub.Therefore, the lantern was removed from the patient¿s body.The same issue occurred with a second lantern.The physician was able to advance a third lantern to the target location.While attempting to advance a ruby coil through the third lantern, the physician kinked the pusher wire of the ruby coil.The inner wire of the ruby coil was exposed and therefore, the ruby coil was removed.It was reported that the physician was able to successfully implant a combination of sixteen ruby coils and pod packing coils.While attempting to advance the next pod pc through the lantern, the physician met resistance.Subsequently, the pusher wire of the pod pc became kinked.Therefore, the pod pc was removed.The procedure was completed using new ruby coils, new pod pc coils, and a new lantern.The physician decided to use a fourth lantern due to sizing.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 1.3005168196-2024-00044.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Common Device Name: 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: 18673483
• Report Number: 3005168196-2024-00043
• Device Sequence Number: 15001349
• Product Code: DQY
• UDI-Device Identifier: 00814548016672
• UDI-Public: 814548016672
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K152840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/08/2024
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2026
• Device Catalogue Number: PXSLIMLAN150STR
• Device Lot Number: F00007079
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2024
• Initial Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005