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

Model Number	PXSLIMLAN115STR
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
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: 3005168196-2021-00757.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the abdominal aortic aneurysm (aaa) sac using pod packing coils (pod pcs), a lantern delivery microcatheter (lantern), and non-penumbra diagnostic catheter.During the procedure, the physician placed two pod pcs in the target location.Subsequently, the next pod pc became stuck inside the lantern after advancing to a certain point and would not retract.It was reported the physician had advanced the diagnostic catheter without a wire and had manipulated the lantern without a wire.When attempting to pull the pod pc back, the pod pc unintentionally detached in the lantern.Therefore, the detached pod pc and lantern were removed together.The lantern was inspected, and the hospital staff noticed the lantern was kinked at the distal shaft, around the area where the pod pc was getting stuck.The procedure was completed using two new pod pcs and a new lantern.There was no report of an adverse effect to the patient.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11668439
• Report Number: 3005168196-2021-00756
• Device Sequence Number: 2980570
• Product Code: DQY
• UDI-Device Identifier: 00814548016610
• UDI-Public: 00814548016610
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/19/2021
• 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: 10/05/2023
• Device Model Number: PXSLIMLAN115STR
• Device Catalogue Number: PXSLIMLAN115STR
• Device Lot Number: F100831
• Was Device Available for Evaluation?: No
• 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: 03/19/2021
• Initial Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80
• Date Report Sent to FDA: 01/01/2005