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

Catalog Number DH1

Device Problem Separation Failure (2547)

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

Event Date 11/04/2014

Event Type  malfunction  

Manufacturer Narrative

Result: the nose cone hole in the detachment handle was damaged.A piece of the pet lock from one of the preceding coils was visible inside the detachment handle.Conclusion: the complaint has been evaluated.The complaint indicated that the detachment handle was used to deliver the first two coils.Upon attempted detachment of the third coil, the coil would not detach.Subsequent coils were attempted but were unsuccessfully detached.Evaluation of the returned product confirms that a piece of pet lock material was inside the penumbra coil detachment handle.It appears that the pet lock material came off inside the handle.Due to how the handle functions, the actuator inside the detachment handle clamps down on the proximal end of the pusher assembly when the handle is used during a coil detachment.This also breaks the pet-lock on the proximal end of the pusher assembly.The hole in the nose cone of the detachment handle was measured and found to be within specification.These devices are 100% functionally tested during incoming inspection.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 splenic artery using a penumbra coil 400 detachment handle and penumbra coil 400 coils.During the procedure, the physician was unable to detach five pc400 coils although the detachment handle had broken the pet lock.The physician purposefully broke the pusher wires and each of the coils was successfully detached in the aneurysm.There was no report of an adverse effect on the patient.

Manufacturer Narrative

Conclusion: this device pusher wire is available for return.A follow up mdr will be submitted upon completion of the device investigation.This mdr is associated with mdr 3005168196-2014-00899, 00900, 00901, 00902, 00914.

• Brand Name: PENUMBRA COIL 400 DETACHMENT HANDLE
• 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: 4357281
• MDR Text Key: 13396200
• Report Number: 3005168196-2014-00898
• 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: 07/31/2017
• Device Catalogue Number: DH1
• Device Lot Number: F44609
• 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?: No
• Date Device Manufactured: 07/09/2014
• 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