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

Catalog Number 4004C1135

Device Problems Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2018

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 in the m1 of the middle cerebral artery (mca) using penumbra coil 400s (pc400s).During the procedure, the physician felt resistance while advancing a pc400 through a px slim delivery microcatheter (px slim) and, consequently, the pusher assembly of the pc400 became kinked.The physician therefore removed the pc400, and the procedure was completed using a new pc400 and the same microcatheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the returned device was fractured approximately 35.0 cm and 54.0 cm from proximal end of the pusher assembly.The distal part of the fractured pusher assembly was not returned.The detached embolization coil had some offset coil winds.Conclusion: evaluation of the returned device revealed the pc400 pusher assembly was fractured and part of the device pusher assembly was not returned.If the device is forcefully advanced while experiencing resistance, damage such as a kink may occur.If the damaged device is further manipulated, the kink may eventually worsen to fracture.Based on the reported complaint, the fractures are likely incidental to the complaint and may have occurred post-procedure during packaging for return to penumbra.The px slim was not returned for evaluation; therefore, the root cause of the initial resistance was unable to be determined.Penumbra coils are visually 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.

• Brand Name: PENUMBRA COIL 400
• Type of Device: HCG, KRD
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7902663
• MDR Text Key: 121563379
• Report Number: 3005168196-2018-01888
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00814548010991
• UDI-Public: 00814548010991
• 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: 01/01/2005,08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4004C1135
• Device Lot Number: F81518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• 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: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1