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

Catalog Number PXSLIM090

Device Problems Inadequacy of Device Shape and/or Size (1583); Sticking (1597)

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

Event Date 04/08/2015

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure for a cerebral aneurysm using penumbra coil 400 (pc400) coils and a px slim delivery microcatheter.During the procedure, the physician successfully deployed and detached six pc400 coils through the slim microcatheter.The physician attempted to deploy a seventh pc400 coil, however, it was too large for the aneurysm sac and it was retracted.Upon retraction, the pc400 coil was became stuck in the slim microcatheter.The physician removed the slim microcatheter with the pc400 coil inside and the procedure continued using a new pc400 coil and a new microcatheter.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 3005168196-2015-00465.

Manufacturer Narrative

Result: the px slim was functional.Conclusion: the complaint has been evaluated.The complaint indicated that the patient was undergoing a coil embolization procedure for a cerebral aneurysm using penumbra coil 400 (pc400) coils and a px slim delivery microcatheter.During the procedure, the physician successfully deployed and detached six pc400 coils through the slim microcatheter.The physician attempted to deploy a seventh pc400 coil, however, it was too large for the aneurysm sac and it was retracted.Upon retraction, the pc400 coil was became stuck in the slim microcatheter.The physician removed the slim microcatheter with the pc400 coil inside and the procedure was continued using a new pc400 coil and a new microcatheter.There was no report of an adverse impact on the patient.Evaluation of the returned devices revealed that the pusher assembly was kinked with the coil attached and no damage to the px slim.This type of damage typically occurs due to improper handling during use.If the pusher is manipulated at an angle while force is being applied, it is likely that damage will occur.The complaint also mentioned that the pc400 coil became stuck inside the px slim.This could have occurred if the rotating hemostasis valve (rhv) was tightened onto the pc400 coil prior to removal.The rhv was untightened by the penumbra investigator, and the pc400 coil was removed from the px slim without an issue.These devices are 100% 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: 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: 4767331
• MDR Text Key: 5779050
• Report Number: 3005168196-2015-00466
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2015

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: 06/30/2017
• Device Catalogue Number: PXSLIM090
• Device Lot Number: F43777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 05/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2014
• 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
• Patient Age: 82 YR