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

Model Number PXSLIMLAN115T45

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2020-01501, 3005168196-2020-01502.

Event Description

The patient was undergoing a coil embolization procedure in the aorta artery using ruby coils, pod packing coils (pod pc), and lantern delivery microcatheter (lantern).During the procedure, the physician placed multiple ruby coils in the target vessel using the lantern.The physician then attempted to advance a pod pc; however, the coil became stuck at the proximal portion of the lantern.Therefore, the physician removed the pod pc and flushed the lantern with saline.While attempting to advance a new pod pc, the same issue occurred at proximal portion of the lantern.Therefore, the pod pc and lantern were removed.The procedure was completed using new pod pcs, ruby coils, and a new lantern.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: there was no visible damage to the lantern.Conclusions: evaluation of the returned lantern revealed a functional device.During the functional test, a demonstration coil was advanced through the lantern and out of the distal tip without an issue.Evaluation of the first returned pod pc revealed offset coil winds on the proximal end of the embolization coil.If the device is forcefully manipulated against resistance, damage such as offset coil winds may occur.During the functional test, resistance was encountered while attempting to re-sheath the podj from its returned position, and the podj could not be re-sheathed at all.Therefore, the functional testing could not be performed.Further evaluation of the first returned podj revealed that the embolization coil was knotted outside the distal tip of the introducer sheath, and the introducer sheath had coagulated blood inside.This damage was likely incidental to the reported complaint.Evaluation of the second returned pod pc could not confirm the reported complaint.During the functional test, resistance was encountered due to coagulated blood inside the introducer sheath, and the podj could not be advanced out of its sheath.The introducer sheath was flushed and the podj still could not be advanced out of its introducer sheath.This damage was likely incidental to the reported complaint.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.Penumbra coils 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.This report is associated with mfr report numbers: 1.3005168196-2020-01501, and 2.3005168196-2020-01502.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10551250
• MDR Text Key: 207567875
• Report Number: 3005168196-2020-01500
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548016627
• UDI-Public: 00814548016627
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2022
• Device Model Number: PXSLIMLAN115T45
• Device Catalogue Number: PXSLIMLAN115T45
• Device Lot Number: F88491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR