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 Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Serious Injury
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 to treat a left leg arteriovenous malformation (avm) off the superficial femoral artery (sfa) using a lantern delivery microcatheter (lantern) and an embolic agent.During the procedure, the physician injected an embolic agent through the lantern for several minutes.Then, the physician attempted to remove the lantern; however, the lantern was stuck due to the embolic agent that was used.Therefore, the physician pulled the lantern back with force.Upon removal of the lantern from the patient, the physician noticed it was broken.The physician then noticed under fluoroscopy that the lantern broke off at the radiopaque marker band located at the distal tip in the sfa.The physician attempted to use a snare device to retrieve the broken tip of the lantern; however, it was unsuccessful.Subsequently, the physician pushed the broken tip of the lantern deep into the avm using the snare device.It was reported that the broken tip of the lantern was left in the avm and that the physician was not worried about it remaining in the avm because it did not have a channel to travel anywhere else in the body.The procedure was completed using a new lantern and an embolic agent.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a left leg arteriovenous malformation (avm) off the superficial femoral artery (sfa) using a lantern delivery microcatheter (lantern) and an embolic agent.During the procedure, the physician injected an embolic agent through the lantern for several minutes.Then, the physician attempted to remove the lantern; however, the lantern was stuck due to the embolic agent that was used.Therefore, the physician pulled the lantern back with force.Upon removal of the lantern from the patient, the physician noticed it was broken.The physician then noticed under fluoroscopy that the lantern broke near the distal end in the sfa.The physician attempted to use a snare device to retrieve the broken end of the lantern; however, it was unsuccessful.Subsequently, the physician pushed the broken end of the lantern deep into the avm using the snare device.It was reported that the broken end of the lantern was left in the avm and that the physician was not worried about it remaining in the avm because it did not have a channel to travel anywhere else in the body.The procedure was completed using a new lantern and an embolic agent.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report 3005168196-2021-01421: evaluation of the returned lantern confirmed a fracture in its distal shaft and revealed stretching and ovalization proximal to the fractured location.If the lantern is forcefully retracted against resistance, the device will likely become stretched and may ovalize.Further retraction against resistance may result in catheter fracture.Based on the reported complaint, the embolic agent used in the procedure likely caused the resistance experienced.The distal fractured segment was not returned for evaluation.Further evaluation of the device revealed an additional fracture in the proximal shaft and a kink in the distal shaft.This damage was likely incidental to the complaint.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.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12072200
• Report Number: 3005168196-2021-01421
• Device Sequence Number: 4765088
• Product Code: DQY
• UDI-Device Identifier: 00814548016627
• UDI-Public: 00814548016627
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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): 08/11/2021
• 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: 04/23/2022
• Device Model Number: PXSLIMLAN115T45
• Device Catalogue Number: PXSLIMLAN115T45
• Device Lot Number: F89804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 08/11/2021
• 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: 14 YR
• Date Report Sent to FDA: 01/01/2005