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

Catalog Number PXSLIMSTR

Device Problems Migration or Expulsion of Device (1395); Premature Activation (1484); Difficult to Remove (1528); Physical Resistance (2578); Difficult to Advance (2920)

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

Event Date 12/18/2013

Event Type  malfunction  

Event Description

The patient was undergoing a procedure to treat a type 3 endoleak with a ruby coil system.During the procedure, the physician was able to deploy two ruby coils through the pxslim delivery microcatheter with no issues; however, on the third coil the physician felt significant resistance.The physician attempted several times to reposition the coil and microcatheter to attempt to deliver the coil; however, was unsuccessful.The physician then decided to remove the entire coil system and upon removal, the physician noted that the coil had detached inside the microcatheter.The physician then attempted to remove the microcatheter with the detached coil inside and unfortunately during the withdrawal, the coil migrated into the 5f diagnostic catheter.The physician then removed the diagnostic catheter to attempt to retrieve the coil; however only a portion of the coil was still in the diagnostic catheter and the rest of the coil lodged in the groin sheath.The physician then manually removed the coil by hand until all of the platinum strands were completely removed from the patient.

Manufacturer Narrative

Result: the pxslim microcatheter is kinked approximately 4.5 cm from the distal tip.Conclusion\: the device was returned for analysis and has been evaluated.The complaint indicates that after two coils were successfully deployed with no issue.On the third coil significant resistance was encountered.Evaluation of the returned product revealed that the pxslim catheter was kinked approximately 4.5 cm from the distal tip.This kink is likely the reason significant resistance was encountered while attempting to deploy the third coil.During retrieval, the coil was unintentionally detached due to excess tensile force placed on the device when pulling back, causing the sr wire to break, detaching the coil in the microcatheter.The cause of the kink in the microcatheter is unknown but was not present when the first two coils were deployed.Therefore, the kink must have occurred during manipulation of the device in patient anatomy.This mdr is associated with mdr 3005168196-2014-00054.

• 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: 3734795
• MDR Text Key: 15115614
• Report Number: 3005168196-2014-00232
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 02/06/2014

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 Catalogue Number: PXSLIMSTR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2014
• Initial Date FDA Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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