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

Model Number PXSLIMLAN135STR

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2021-00781.

Event Description

The patient was undergoing a coil embolization procedure in the superior mesenteric artery using a lantern delivery microcatheter (lantern) and guidewire.It was reported the patient¿s anatomy was highly tortuous.During the procedure, the physician implanted seven ruby coils in the target location.When the next ruby coil was retracted from the aneurysm for reforming, the ruby coil unintentionally detached in the lantern.The physician then retrieved the detached ruby coil and lantern.Subsequently, the physician reinserted the same lantern.When advancing the lantern along the guidewire, the physician encountered resistance.Therefore, the lantern was retrieved again.The physician resumed the procedure with a new lantern.No additional coils were implanted.It was determined the embolization had been completed when the confirmation contrast was performed.There was no report of an adverse effect to the patient.

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:3005168196-2021-00782 1.Section h.Box 3.Report source.Evaluation of the returned lantern revealed an ovalization on the distal shaft.Manipulation of the device within the reported tortuous anatomy of the patient may have contributed to this damage.This damage may have contributed to the resistance experienced during the procedure.During functional testing, the lantern with the guidewire inserted into the lanterns lumen was advanced through a demonstration benchmark without an issue.A demonstration ruby coil was advanced through the lantern without an issue.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.This report is associated with mfr report number: 1.3005168196-2021-00781.H3 other text: placeholder.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11691094
• MDR Text Key: 247732014
• Report Number: 3005168196-2021-00782
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016641
• UDI-Public: 00814548016641
• Combination Product (y/n): Y
• PMA/PMN Number: K152840
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/23/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2023
• Device Model Number: PXSLIMLAN135STR
• Device Catalogue Number: PXSLIMLAN135STR
• Device Lot Number: F102591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/19/2021
• Supplement Dates Manufacturer Received: 05/07/2021
• Supplement Dates FDA Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR