MAUDE Adverse Event Report: CORDIS NEUROVASCULAR, INC. UNKNOWN PROWLER CATALOG NUMBER; CES MICROCATHETERS (KRA)

Catalog Number 606XXX

Device Problem Obstruction of Flow (2423)

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

Event Date 12/27/2013

Event Type  malfunction  

Event Description

During an embolization procedure of a 4 x 43mm aneurysm, the surgeon put the prowler 14 microcatheter in place and then positioned the 1st orbit rdfl complex mini coil.The coil could not reach the aneurysm, and when the surgeon withdrew the coil , he noted the coil had detached and stretched into the microcatheter.He changed to another one to complete the procedure.There were no patient adverse events.

Manufacturer Narrative

Concomitant medications were not reported.(b)(6).The lot/catalog numbers were not provided.The gender, age, and weight of patient were not provided.Additional information will be submitted within 30 days of receipt.This is 1 of 2 mdr reports associated with sr#(b)(4).

Manufacturer Narrative

This is 1 of 2 mdr reports associated with patient identifier #(b)(6).No additional information, including lot number, could be obtained.Complaint conclusion: during an embolization procedure of a 4 x 43mm aneurysm, the surgeon put the prowler 14 microcatheter (lot and catalog numbers not provided) in place and then positioned the 1st orbit rdfl complex mini coil (638mf0410/15916043).The coil could not reach the aneurysm, and when the surgeon withdrew the coil , he noted the coil had detached and stretched into the microcatheter.He changed to another one to complete the procedure.There were no patient adverse events.A non-sterile orbit rdfl complex mini coil was received coiled inside of dispenser inside of plastic bag.The orbit complex mini was removed from the dispenser for the analysis.The hypotube was inspected and it was found without damage.The introducer was received un-zipped and it was found without damage.The support coil and gripper were received outside of the introducer and were inspected.The support coil was found without damage.The gripper was found without damage, but the head piece of the embolic coil was found attached to the gripper while the rest of the embolic coil was received stretched.The gripper and headpiece were inspected under microscope; the gripper was found without damage.The soldered section between headpiece and the coil loops was not fractured, so this means that the solder had a good adhesion to the headpiece.The rest of the embolic coil was received stretched.The od from the delivery tube was measured and was found within specification.The functional test could not be performed due to the condition the support coil outside the introducer.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.The microcatheter was not returned and a review of manufacturing documentation was not possible without the sterile lot number.The inability to deliver the coil to the aneurysm could not be confirmed due to the condition of the returned product and no return of the microcatheter.Premature detachment was not confirmed due to the adhesion of the headpiece in the gripper; however coil stretching was confirmed.The cause of the failure experienced by the costumer and the damages found on the device could not be conclusively determined; however, applying excessive force during withdrawal may have contributed to the coil stretching.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process, therefore, no corrective action will be taken at this time.

• Brand Name: UNKNOWN PROWLER CATALOG NUMBER
• Type of Device: CES MICROCATHETERS (KRA)
• Manufacturer (Section D): CORDIS NEUROVASCULAR, INC.; 14700 nw 57th court; miami lakes FL 33014
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC (SAN JOSE); 821 fox lane; san jose CA 95131
• Manufacturer Contact: denise singleton ; miami lakes, FL 33014 ; 4084331514
• MDR Report Key: 3592647
• MDR Text Key: 4138643
• Report Number: 1058196-2014-00028
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K021591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2014

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: Health Professional
• Device Catalogue Number: 606XXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/18/2014
• Initial Date FDA Received: 01/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1