MAUDE Adverse Event Report: PENUMBRA, INC. PX SLIM DELIVERY MICROCATHETER; DQY

Catalog Number PXSLIM045

Device Problems Detachment Of Device Component (1104); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2014

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure using a penumbra coil 400 and a px slim delivery microcatheter.During the procedure, as the physician attempted to remove the coil due to the incorrect size, the coil unintentionally detached within the microcatheter after some resistance.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.This mdr is associated with mdr 3005168196-2014-00895.

Manufacturer Narrative

Result: there was no visual damage to the px slim.The inner diameter of the microcatheter was measured and determined to be within specification.Conclusion: the complaint has been evaluated.The complaint indicates that after resistance was felt, the pc400 coil detached inside the px slim.Evaluation of the returned product confirmed that the pc400 detached unintentionally.The pull wire was inside the ddt capture feature, therefore there was no attempt to detach the coil.The coil and microcatheter specifications were measured and determined to be within specification therefore, the devices should have been compatible.It appears that the coil was pushed against resistance causing the pusher assembly to kink, allowing the pull wire to retract and release the coil.The cause of the resistance could not be determined based on the description of the event.The coils and microcatheter's are 100% visually inspected for damage and the coils are 100% functionally tested during process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PX SLIM DELIVERY MICROCATHETER
• Type of Device: DQY
• 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: 4354501
• MDR Text Key: 5221358
• Report Number: 3005168196-2014-00896
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K100826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• 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: 02/28/2017
• Device Catalogue Number: PXSLIM045
• Device Lot Number: F41505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2015
• Initial Date FDA Received: 12/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2014
• 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