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

Model Number	PXSLIMLAN135T90
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
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: 3005168196-2020-02149 and 3005168196-2020-02150.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the splenic artery using a lantern delivery microcatheter (lantern), ruby coils, pod packing coils (pod pcs) and a neuron 6f 070 delivery catheter (neuron 070).It was noted that the patient anatomy was tortuous.During the procedure, the physician placed five ruby coils into the target location using a neuron 070, a lantern (f88021) and a pressurized flush bag that was connected to the lantern via a rotating hemostasis valve (rhv).Afterwards, the flush stopped running through the lantern.Therefore, the pressurized flush bag was disconnected from the lantern and it worked when the pressurized bag was not connected to the lantern.The following penumbra coils advanced through the lantern fine while flushing the lantern with saline using a syringe.However, since it was a large aneurysm and continuous flush was desired, the lantern was removed.Next, the physician placed five additional ruby coils in the target location using the new second lantern (f85839), the neuron 070, and the pressurized flush bag that was connected to the new lantern via a rotating hemostasis valve (rhv).Afterwards, once again, it was noticed that the flush stopped running through the lantern.Therefore, the pressurized flush bag and the rhv were removed and replaced with new ones.However, no flush through the lantern was observed.Therefore, the lantern was removed.Then, while the physician used the new third lantern (f87160), the same issue occurred.No flush through the lantern was observed while the lantern was connected to a pressurized flush bag via a rotating hemostasis valve (rhv).It was also reported that the neuron 070 was not tight around the lantern.The procedure was completed using a mixture of twenty additional ruby coils and pod packing coils (pod pcs), the same third lantern and the same neuron 070.It was reported that the physician had to flush the third lantern with each of the twenty ruby coils that were placed to complete the procedure.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the third returned lantern was kinked approximately 2.0 cm form the hub.Conclusions: evaluation of the first returned lantern revealed a functional device.During functional testing, the lantern was connected to the returned rotating hemostasis valve (rhv) and the flow switch.Then bleach solution was able to flush through the lantern from the flow switch without issue.Further evaluation of the device revealed distal ovalizations.This damage was likely incidental to the complaint.Evaluation of the second returned lantern revealed a functional device.During functional testing, the lantern was connected to the returned rotating hemostasis valve (rhv) and the flow switch.Then bleach solution was able to flush through the lantern from the flow switch without issue.Evaluation of the third returned lantern revealed a functional device.During functional testing, the lantern was connected to the returned rotating hemostasis valve (rhv) and the flow switch.Then bleach solution was able to flush through the lantern from the flow switch without issue.Further evaluation of the device revealed a kink near its proximal end.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.This report is associated with mfr report numbers: 1.3005168196-2020-02149 2.3005168196-2020-02150 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: 10931096
• Report Number: 3005168196-2020-02151
• Device Sequence Number: 545263
• Product Code: DQY
• UDI-Device Identifier: 00814548016665
• UDI-Public: 00814548016665
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K152840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020
• 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: 11/26/2021
• Device Model Number: PXSLIMLAN135T90
• Device Catalogue Number: PXSLIMLAN135T90
• Device Lot Number: F87160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 12/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005