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

Catalog Number 4002C1557

Device Problem Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/04/2014

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure using a penumbra coil 400 coils.During the procedure, the physician repositioned the pc400 coil multiple times.The physician attempted to advance the pc400 coil again, yet it would not advance.The pc400 removed and the procedure continued using additional coils.There was no report of an adverse effect on the patient.

Manufacturer Narrative

Conclusion: the device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Manufacturer Narrative

Result: the pc400 coil was intact with the pusher assembly.The pet lock was intact on the proximal end of the pusher assembly.The pusher assembly was kinked approximately 5.0 cm from the proximal end.The pusher assembly also had multiple kinks along the entire hypo-tube.The coil was crushed approximately 5.0 cm from the proximal end.The outer diameter of the coil (in the undamaged region), and the distal detachment tip (ddt) were measured and determined to be within specification.Conclusion: the complaint has been evaluated.The complaint indicates that the pc400 coil could be withdrawn, but could not be advanced.Evaluation of the returned product revealed that the coil was damaged in several locations.In addition, the coil pusher assembly was kinked.Based on the condition of the returned device, it appears that the coil was damaged during manipulation in the patient causing resistance when attempting to advance the coil during placement.The multiple kinks along the length of the pusher assembly were likely due to handling the device during packaging for return.These devices are 100 % functionally tested and visually inspected for damage during process inspection.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.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; 1351 harbor bay parkway; alameda, CA 94502 ; 5107483200
• MDR Report Key: 4357285
• MDR Text Key: 5203724
• Report Number: 3005168196-2014-00903
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/25/2014

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: Physician
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 4002C1557
• Device Lot Number: F41576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2014
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1