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

Catalog Number PXSLIM045

Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Device Dislodged or Dislocated (2923)

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

Event Date 09/05/2014

Event Type  malfunction  

Manufacturer Narrative

Result: a 0.025" mandrel was introduced through the hub of the px slim delivery microcatheter and advanced distally without an issue.The microcatheter was functional.Conclusion: the complaint has been evaluated.The compliant indicates the px slim delivery microcatheter kicked out of the aneurysm while attempting to advance the penumbra coil 400.The px slim delivery microcatheter was then repositioned and while attempting to retract the penumbra coil 400, the px slim delivery microcatheter, stent, and penumbra coil 400 all shifted in the anatomy.While attempting to retract the penumbra coil 400, it unintentionally detached.The px slim delivery microcatheter was removed and the penumbra coil 400 required a gooseneck snare to retrieve it.The stent was also removed.Evaluation of the returned devices confirmed that the penumbra coil 400 and the liberty stent were snared and removed from the patient.During evaluation, both microcatheters revealed to be functional.The penumbra coil 400 pusher assembly was kinked in the distal and proximal areas of the wire.In addition, the complaint indicated that the pc400 coil was unintentionally detached; however, the pet-lock was broken indicating that the pc400 coil was attempted to be detached.The root cause of this compliant cannot be determined.All the devices involved in this incident are 100% functional tested during in-process 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 stent assisted coil embolization procedure in the left internal carotid artery (ica) using a velocity deliver microcatheter, a px slim delivery microcatheter, and a penumbra coil 400.During the procedure, the px slim delivery microcatheter kicked out of the aneurysm while attempting to advance the penumbra coil 400.The physician repositioned the px slim delivery microcatheter and while attempting to retract the penumbra coil 400, the px slim delivery microcatheter, stent, and penumbra coil 400 all shifted in the anatomy.While attempting to retract the penumbra coil 400 and the stent, they both unintentionally detached.The px slim delivery microcatheter was removed and the penumbra coil 400 required a gooseneck snare to retrieve it.The procedure continued successfully with new devices.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 3005168196-2014-00694 and 00696.

• 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: 4263040
• MDR Text Key: 13094930
• Report Number: 3005168196-2014-00695
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: PXSLIM045
• Device Lot Number: F38051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2015
• Initial Date FDA Received: 11/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR