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

Model Number	PXSLIMLAN115STR
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the gastric varices using a lantern delivery microcatheter (lantern) and non-penumbra angled diagnostic catheter.During the procedure, the physician was able to take down a varix without issue using the lantern.Subsequently, the lantern was removed to do a venogram of the portal system to locate additional varices.Once the additional varices were located, the lantern was reintroduced over a 0.016 wire.While advancing the lantern to the new embolization location, the physician noticed the lantern was kinked and broken.Therefore, the lantern was removed by pulling it out.It is unknown where the kink/ break occurred on the lantern, but the area of the break did not enter the diagnostic catheter.It is also unknown if the damage to the lantern occurred while advancing into the diagnostic catheter or if it occurred while removing the lantern after the first embolization.The procedure was completed using a new lantern and a new straight catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned lantern confirmed that the catheter was fractured.If the lantern is forcefully mishandled during use at an extreme angle, damage such as a kink and subsequent fracture may occur.Penumbra catheters are visually 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
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11023750
• Report Number: 3005168196-2020-02287
• Device Sequence Number: 11718092
• 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,Followup
• Report Date (Section B): 11/20/2020
• 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: 07/14/2023
• Device Model Number: PXSLIMLAN115STR
• Device Catalogue Number: PXSLIMLAN115STR
• Device Lot Number: F98877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Date Report Sent to FDA: 01/01/2005