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

Model Number	PXSLIMLAN115T45
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ruby coil pusher assembly confirmed that the embolization coil was detached from the pusher assembly.Further evaluation revealed that the pet lock was separated on the proximal end of the pusher assembly and the pull wire was retracted out of the ddt.If this occurs, the embolization coil will detach from its pusher assembly.This likely contributed to the embolization coil detaching from its pusher assembly upon removal within the lantern during the procedure.The detached embolization coil mentioned in the complaint was not returned for evaluation.Further evaluation of the returned device revealed kinks throughout the pusher assembly.This damage was likely incidental to the complaint and may have occurred during packaging for the device returned.Evaluation of the returned lantern revealed an unknown material within the catheter.During functional testing, a demonstration ruby coil was attempted to advance through the lantern and resistance was encountered due to the unknown material inside the catheter.The demonstration ruby coil could not be advanced any further.While retracting the demonstration ruby coil from the lantern resistance was encountered and the ruby coil was detached inside the lantern.This unknown material may have contributed to the reported resistance experienced during the procedure.The root cause of the unknown material inside the lantern could not be determined.Further evaluation revealed a proximal kink.This damage was likely incidental to the complaint.Penumbra coils and 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.This report is associated with mfr report number: 3005168196-2021-00421.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal iliac artery (iia) using ruby coils, a lantern delivery microcatheter (lantern), and a parent catheter.During the procedure, the physician placed a parent catheter and lantern in the target location and then flushed the lantern.Afterwards, the physician experienced resistance while advancing a ruby coil through the lantern and decided to retract the ruby coil.However, upon retraction, the ruby coil unintentionally detached inside mid-shaft of the lantern.Therefore, the lantern containing the detached ruby coil was removed.The procedure was completed using a new ruby coil and another microcatheter.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: 11435892
• Report Number: 3005168196-2021-00422
• Device Sequence Number: 3117376
• Product Code: DQY
• UDI-Device Identifier: 00814548016627
• UDI-Public: 00814548016627
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K152840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2021
• 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: 07/14/2022
• Device Model Number: PXSLIMLAN115T45
• Device Catalogue Number: PXSLIMLAN115T45
• Device Lot Number: F91728
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• 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: 02/07/2021
• Initial Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005