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

Catalog Number PXSLIMSTR

Device Problems Partial Blockage (1065); Detachment Of Device Component (1104); Failure to Advance (2524); Physical Resistance (2578)

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

Event Date 05/28/2014

Event Type  malfunction  

Event Description

The patient was undergoing a coil embolization procedure using a px slim delivery microcatheter and ruby coils.During the procedure, the physician was unable to advance the ruby coil into px slim delivery microcatheter.The physician removed the entire ruby coil from the introducer and re-loaded the ruby coil into the introducer; however, the ruby coil would not advance smoothly through the px slim delivery microcatheter.Several attempts were made to flush the coil inside the introducer sheath before trying to pass it though px slim delivery microcatheter; however, the ruby coil buckled inside the rotating hemostatic valve (rhv).The ruby coil was removed and another ruby coil was used.When the second ruby coil was removed its package, a similar incident occurred.The ruby coil seemed wedged inside the introducer sheath and unable to pass through the px slim delivery microcatheter with huge resistance and buckling back into the rhv.The second ruby coil was removed and another ruby coil was used.The first few centimeters of the third ruby coil began to pass through px slim delivery microcatheter; however, a sticky resistance feeling occurred.As the physician pulled back on the ruby coil, it unintentionally detached inside the px slim delivery microcatheter.The ruby coil and the px slim delivery microcatheter were removed and new ones were used.There was no report of an adverse effect on the patient.

Manufacturer Narrative

Conclusion: the product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This mdr is associated with mdr 3005168196-2014-00797, 00798, and 00799.Device was disposed of by hospital.

• 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: 4233295
• MDR Text Key: 19303204
• Report Number: 3005168196-2014-00796
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 05/28/2014

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: 09/30/2015
• Device Catalogue Number: PXSLIMSTR
• Device Lot Number: F31539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2014
• Initial Date FDA Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2012
• 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