MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA COIL 400; HCG, KRD

Model Number 4004C0408-A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2020

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 number: 1.3005168196-2020-00446.

Event 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.

Manufacturer Narrative

Results: the total length of the pusher assembly was approximately 109.0 cm; therefore, the pusher assembly was fractured approximately 66.0 cm from the proximal end.The pusher assembly had bends along its length.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: 1.3005168196-2020-00446 h3 other text : placeholder.

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:3005168196-2020-00445.Results: the pet lock was separated on the proximal end of the pusher assembly and the pull tube was retracted and kinked.The pusher assembly was fractured approximately 67.0 cm from the proximal end.The pusher assembly had bends along its length.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: 1.3005168196-2020-00446.

• Brand Name: PENUMBRA COIL 400
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9886560
• MDR Text Key: 185228434
• Report Number: 3005168196-2020-00445
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548018430
• UDI-Public: 00814548018430
• Combination Product (y/n): Y
• PMA/PMN Number: K173614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,03/04/2020

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 Model Number: 4004C0408-A
• Device Catalogue Number: 4004C0408
• Device Lot Number: F90201
• 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 03/26/2020
• Supplement Dates Manufacturer Received: 04/23/2020; 01/14/2005
• Supplement Dates FDA Received: 05/18/2020; 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24 YR