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

Model Number 4004C0815

Device Problem Premature Separation (4045)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a coil embolization procedure using a penumbra coil 400 (pc400) and px slim delivery microcatheter (px slim).During the procedure, the pc400 unintentionally detached inside the px slim; therefore, the px slim and pc400 were removed.No additional information regarding the completion of the procedure was provided.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 115.0 cm and 117.0 cm from the proximal end.The stretch resistance wire (sr wire) was fractured and the proximal constraint sphere was present inside the distal detachment tip (ddt).The embolization coil was detached from the pusher assembly and not returned for evaluation.Conclusions: evaluation of the returned pc400 revealed that the embolization coil was detached due to the sr wire fracture.If the embolization coil is forcefully retracted against resistance, the sr wire may become fractured and allow the embolization coil to detach from the proximal constraint sphere.The px slim used in the procedure and the detached embolization coil were not returned for evaluation; therefore, the root cause of the resistance could not be determined.Further evaluation revealed pusher assembly kinks.These kinks were likely incidental to the complaint and may have occurred during packaging for return to penumbra.Penumbra coils 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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the cause of the detachment issue.

Event Description

The patient was undergoing a coil embolization procedure using a penumbra coil 400 (pc400) and px slim delivery microcatheter (px slim).During the procedure, while advancing the pc400 through the px slim, the pc400 unintentionally detached inside the px slim.Therefore, the physician removed the px slim containing the detached pc400 and then removed the pc400.The procedure was completed using a new pc400 and the same px slim.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following section has been updated based on additional information provided on (b)(6) 2020: 1.Section b.Box 5.Describe event or problem.

• Brand Name: PENUMBRA COIL 400
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9536329
• MDR Text Key: 177213503
• Report Number: 3005168196-2019-02439
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548011707
• UDI-Public: 00814548011707
• Combination Product (y/n): Y
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4004C0815
• Device Catalogue Number: 4004C0815
• Device Lot Number: F90919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• 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: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR