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

Model Number 4004C0820

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a coil embolization procedure in the pulmonary veins using penumbra coil 400's (pc400's).It should be noted that the target vessel was accessed via the right femoral artery (fa) using a lantern delivery microcatheter (lantern) and a non-penumbra guide catheter.During the procedure, the physician placed the first pc400 into the target vessel and decided to retract the coil to reposition it.It was then reported that the pc400 would "not come with the delivery pusher".The pc400 and lantern were then removed from the patient and the pc400 was removed from the lantern.No additional information regarding the issue with the pc400 is available.The same lantern was then re-advanced into the target vessel and the procedure was completed using six additional pc400's and six non-penumbra coils.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following sections were inadvertently missed on the initial mfr report and are being updated on this follow-up #01 mfr report:3005168196-2019-00717.Section e.Box 2.Health professional.Section e.Box 3.Occupation.

• Brand Name: PENUMBRA COIL 400
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8522767
• MDR Text Key: 142729570
• Report Number: 3005168196-2019-00717
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548010922
• UDI-Public: 00814548010922
• 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
• Report Date: 01/01/2005,03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4004C0820
• Device Catalogue Number: 4004C0820
• Device Lot Number: F79816
• Was Device Available for Evaluation?: No
• 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: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1