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

Model Number	PXSLIMSTR-B
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional 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 number: 1.3005168196-2020-00445.
Event or Problem Description
The patient was undergoing a coil embolization procedure to treat a carotid cavernous fistula (ccf) in the internal carotid artery (ica) using a penumbra coil 400 (pc400) and a px slim delivery microcatheter (px slim).During the procedure, the physician successfully placed a pc400 into the target vessel using the px slim.Upon removal of the pusher assembly, it was noticed that the pusher assembly broke into two pieces, leaving a broken piece stuck within the px slim.Therefore, the px slim containing the broken piece of the pusher assembly was removed.The procedure was completed using additional pc400s and a new px slim.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Results: the px slim was kinked approximately 67.5 cm from the hub.Conclusions: evaluation of the returned pc400 and lantern confirmed a fractured pusher assembly and revealed that the lantern was kinked at the same location as the proximal end of the pusher assembly while the pusher assembly was within the lantern.If the devices are advanced against resistance or are otherwise mishandled at extreme angles during use, damage such as a kink may occur.Subsequently, if the kinked pusher assembly is further manipulated, damage such as a fracture may occur.During functional testing, a demonstration pc400 was advanced and retracted through the returned lantern without an issue.Penumbra coils and 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: 1.3005168196-2020-00445.
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:3005168196-2020-00446 results: the px slim was kinked approximately 67.5 cm from the hub.Conclusions: evaluation of the returned pc400 and lantern confirmed a fractured pusher assembly and revealed that the lantern was kinked at the same location as the proximal end of the pusher assembly distal fractured segment while the pusher assembly was within the lantern.If the devices are advanced against resistance or are otherwise mishandled at extreme angles during use, damage such as a kink may occur.Subsequently, if the kinked pusher assembly is further manipulated, damage such as a fracture may occur.During functional testing, a demonstration pc400 was advanced and retracted through the returned lantern without an issue.Further evaluation of the returned pc400 revealed the pet lock was separated on the proximal end of the pusher assembly and additional pusher assembly kinks.These damages were likely incidental to the reported complaint.Penumbra coils and 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: 1.3005168196-2020-00445.

• Brand Name: LANTERN DELIVERY MICROCATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9886559
• Report Number: 3005168196-2020-00446
• Device Sequence Number: 2897298
• Product Code: DQY
• UDI-Device Identifier: 00814548016443
• UDI-Public: 00814548016443
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 03/04/2020
• 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: 05/19/2022
• Device Model Number: PXSLIMSTR-B
• Device Catalogue Number: PXSLIMSTR
• Device Lot Number: F90403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 04/23/2020; 01/14/2005
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 05/18/2020; 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Date Report Sent to FDA: 01/01/2005