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

Catalog Number	PXSLIMLAN150STR
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation of the returned lantern confirmed that the device was fractured on its distal shaft.If the lantern is retracted against resistance, damage such as a fracture may occur.It was reported that the patient¿s anatomy was tortuous.This likely contributed to the resistance.The distal fractured segment was not returned for evaluation.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.
Event or Problem Description
The patient was undergoing an embolization procedure in the marginal artery using a lantern delivery microcatheter (lantern), a non-penumbra microcatheter, a non-penumbra sheath (5fr x 10cm), and a guidewire (.014, 300cm).It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician started with the non-penumbra microcatheter, but it did not have enough length, so he exchanged to the lantern over the guidewire.The physician was searching for a bleed in the marginal artery; however, noticed under fluoroscopy that he was in a small collateral vessel, so the guidewire was reinserted into the lantern and the lantern was retracted.The guidewire was then removed and another image was taken; however, at this time, the physician noticed that the tip of the lantern was distal to where the contrast was coming out.The physician could visualize under fluoroscopy that the lantern¿s distal 3cm tip (radiopaque marker to radiopaque marker) had broken off into the marginal artery.The physician decided to leave the fractured lantern tip in the patient''s vessel to not cause any additional harm.The procedure ended at this point.It is reported that the patient is stable and there was no additional blood loss.

• 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: 20014935
• Report Number: 3005168196-2024-00283
• Device Sequence Number: 15234716
• Product Code: DQY
• UDI-Device Identifier: 00814548016672
• UDI-Public: 00814548016672
• 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): 08/16/2024
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PXSLIMLAN150STR
• Device Lot Number: F00009508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2024
• 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: 07/22/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005