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

Model Number	PXSLIMLAN115T45
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	05/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Potential adverse events in the labeling with the penumbra delivery microcatheter include, but are not limited to, hematoma or hemorrhage at the site, vessel spasm, thrombosis, dissection, perforation or rupture, including death.Evaluation of the returned lantern confirmed that the catheter was fractured.This damage inadvertently occurred while wiping the device after it was removed from the patient as mentioned in the complaint.Further evaluation revealed ovalization on the distal shaft.This damage was incidental to the reported complaint and the root cause could not be determined.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.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a type ii endoleak located on a branch of the iliolumbar artery using a lantern delivery microcatheter (lantern), ruby coils, and a non-penumbra support catheter.During the procedure, it was noted that many small branches were coming off the iliolumbar artery and the physician spent approximately thirty to forty-five minutes searching for the target branch.After locating the target branch, the physician began navigating through the vasculature and inadvertently advanced the lantern up the wrong branch.Resistance was encountered while advancing the lantern and it was noted that the branch was small.The lantern was unable to continue tracking and subsequent imaging revealed that a vessel perforation had occurred.While advancing a ruby coil through the vessel to embolize the perforation, resistance was encountered, and the lantern was pushed out of position.It was reported that the ruby coil was too large, and the vessel was too small; therefore, the ruby coil and lantern were removed from the patient.While wiping down the lantern with wet gauze on the back table, the technician inadvertently broke it.Therefore, the lantern was no longer used in the procedure.A new lantern was then used for imaging and subsequently removed because it was decided that the target branch would be too difficult to access.It was also noted that the vessel perforation had occluded on its own and no additional coils were needed.Therefore, the procedure was discontinued.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11925498
• Report Number: 3005168196-2021-01221
• Device Sequence Number: 3911330
• Product Code: DQY
• UDI-Device Identifier: 00814548016627
• UDI-Public: 00814548016627
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 05/04/2021
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/04/2023
• Device Model Number: PXSLIMLAN115T45
• Device Catalogue Number: PXSLIMLAN115T45
• Device Lot Number: F102496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• 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: 05/04/2021
• Initial Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Date Report Sent to FDA: 01/01/2005