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

Model Number	PXSLIMLAN150T45
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2021
Type of Reportable Event	Malfunction
Additional 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 numbers: 3005168196-2021-01144 and 3005168196-2021-01145.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the pulmonary artery using a lantern delivery microcatheter (lantern), pod coils, pod packing coils (pod pcs), and a non-penumbra catheter.It should be noted that the patient's anatomy was tortuous.During the procedure, the physician encountered resistance while advancing a pod coil; however, the pod coil was successfully implanted.Next, the physician encountered resistance while advancing a pod pc through the middle of the lantern.Therefore, the pod pc and lantern were removed from the procedure.The procedure was completed using a new lantern to implant the same pod pc, one additional pod pc of the same size, and three non-penumbra coils.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned lantern revealed a functional device.During the functional test, a demonstration coil was advanced through the returned lantern without an issue.The root cause of resistance during the procedure could not be determined.Further evaluation revealed a kinked strain relief.This damage was likely incidental to the reported complaint.The strain relief was unraveled and there was no kink in the proximal shaft of the lantern.Penumbra catheters 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: 1.3005168196-2021-01144, 2.3005168196-2021-01145.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: 11871483
• Report Number: 3005168196-2021-01143
• Device Sequence Number: 3202629
• Product Code: DQY
• UDI-Device Identifier: 00814548016689
• UDI-Public: 00814548016689
• 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,Followup
• Report Date (Section B): 04/26/2021
• 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: 11/24/2023
• Device Model Number: PXSLIMLAN150T45
• Device Catalogue Number: PXSLIMLAN150T45
• Device Lot Number: F102300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 76
• Date Report Sent to FDA: 01/01/2005