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

Catalog Number PXSLIMLAN115T45

Device Problems Device Slipped (1584); Material Deformation (2976); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2017

Event Type  malfunction  

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: 3005168196-2017-01418.The hospital disposed of the device.

Event Description

The patient was undergoing a coil embolization procedure in the hypogastric artery using pod packing coils (podjs) and a lantern delivery microcatheter (lantern).During the procedure, the physician successfully deployed and detached three penumbra coils into the target vessel using the lantern.Half way through the procedure, the scrub technologist took a break and a new technologist stepped in with no experience using penumbra coils.Consequently, while attempting to advance a new podj into the lantern, the technologist mishandled the coil and inadvertently bent the podj pusher assembly.Therefore, the introducer sheath containing the podj was removed.Next, a new podj was opened and deployed and detached into the target vessel.The physician then removed the lantern because he wanted to reposition the non-penumbra selective catheter.Upon reinserting the lantern into the patient, the physician did not use a guidewire.Subsequently, the lantern tracked through a side branch, then prolapsed and became creased.Therefore, the lantern was removed and the procedure was completed using the same non-penumbra selective catheter, a new lantern and additional podjs and ruby coils.There was no report of an adverse effect to the patient.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Type of Device: 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: 6812208
• MDR Text Key: 83537243
• Report Number: 3005168196-2017-01419
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016627
• UDI-Public: 00814548016627
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/16/2020
• Device Catalogue Number: PXSLIMLAN115T45
• Device Lot Number: F75059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR