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

Catalog Number 606S1XXX

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2013

Event Type  malfunction  

Event Description

During the coil embolization procedure of an unknown vessel, these 2 coils (micrusphere 10 cerecyte microcoil (b)(4) and presidio 18 cerecyte microcoil (b)(4)) were pre-detached while advancing in the middle section of the prowler select lp (mc) microcatheter.Both devices were removed very safely.The procedure was successfully done without any adverse events and with the same mc.No additional torque or manipulation was used when advancing the coil systems through the microcatheter, and a constant and dedicated saline source was used at all times through the microcatheter.The microcatheter was not reshaped, and after the event, no damages were noticed on either device (kink, bend, fracture, stretched, etc.).Both components were going to be return for analyses, but to date neither device has been received.Addendum (b)(4) 2014: additional information confirmed that the microcatheter used with the device was prowler select lp instead of an excelsior sl 10.

Manufacturer Narrative

Concerning the returned prowler select microcatheter (lot unknown) was visually inspected under high microscopic settings and no damage to the tube was found.The prowler microcatheter was then flushed with no obstructions found.A 0.014¿ guide wire was then advanced through the microcatheter and no resistance encountered.Using a 10 series compatible new microcoil system and the returned damaged prowler select lp microcatheter (lot unknown), the coil was introduced multiple times with no resistance encountered.The coil was then advanced through and out the distal tip of the microcatheter with no problems encountered.Therefore, it is highly unlikely that this prowler select lp microcatheter, by itself, did not contribute to the field complaint.However, without the returned of the severed distal 31.0 centimeters of the prowler select lp microcatheter used in the procedure, it cannot be determined if this component had any additional contributions to the complaint event.In addition, the echelon 10 microcatheter as stated in the complaint event was not returned.Review of the manufacturing dhr documentation could not be performed as the lot number remains currently unknown.The reported event of coil premature detachment was confirmed.The most likely root cause of the unintended detachment is the coil becoming anchored within the microcatheter during advancing.Due to the returned condition of the device functional testing for insertion through the microcatheter cannot be performed, however the concomitant microcatheter was tested with a lab sample and the microcoil advanced without any issue.Based on the available information and analysis of the returned device, no conclusion can be made regarding the reported advancing difficulty during insertion of the microcoil through the codman microcatheter.It appears that advancing difficulty through the microcatheter may have led to the detachment of the coil.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.This is one of 3 products associated with sr (b)(4).Also the device noted represents a prowler select lp microcatheter with unknown catalog and lot number.

Manufacturer Narrative

During the coil embolization procedure of an unknown vessel these 2 coils (micrusphere 10 cerecyte microcoil csp10050030/c17119 and presidio 18 cerecyte microcoil pc418124030/ c17493) were pre-detached while advancing in the middle section of the prowler select lp (mc) microcatheter (catalog and lot unk).Both devices were removed very safely.The procedure was successfully done without any adverse events and with the same mc.No additional torque or manipulation was used when advancing the coil systems through the microcatheter, and a constant and dedicated saline source was used at all times through the microcatheter.The microcatheter was not reshaped, and after the event, no damages were noticed on either device (kink, bend, fracture, stretched, etc.).All the components were returned for analyses.Concerning the returned prowler select microcatheter (lot unknown) was visually inspected under high microscopic settings and no damage to the tube was found.The prowler microcatheter was then flushed with no obstructions found.A 0.014¿ guide wire was then advanced through the microcatheter and no resistance encountered.Using a 10 series compatible new microcoil system and the returned damaged prowler select lp microcatheter (lot unknown), the coil was introduced multiple times with no resistance encountered.The coil was then advanced through and out the distal tip of the microcatheter with no problems encountered.Therefore, it is highly unlikely that this prowler select lp microcatheter, by itself, did not contribute to the field complaint.However, without the returned of the severed distal 31.0 centimeters of the prowler select lp microcatheter used in the procedure, it cannot be determined if this component had any additional contributions to the complaint event.Additional analysis, indicated that a non-sterile unknown prowler select lp microcatheter was received coiled inside of a plastic bag.In plastic bag was received vessel unknown (micrusphere 10 cerecyte microcoil csp10050030/(b)(4) and presidio 18 cerecyte microcoil pc418124030/ (b)(4)).A coil was received deployed and stretched.The micrusphere 10 cerecyte microcoil csp10050030/(b)(4) was inspected found without damage while the presidio 18 cerecyte microcoil pc418124030/ (b)(4) was found kinked.No damages were noted on the hub of microcatheter.The body the microcatheter was inspected and was found kinked and it was cut due to presented cut characteristic distal end.The microcatheter and presidio 18 cerecyte microcoil pc418124030/ (b)(4) were inspected under microscope; it was found damage.The id the microcatheter was measured and was found within specification.After that prowler select lp microcatheter was flushed out using a lab sample syringe (nipro) the water came out from the distal end of the device.Then a 0.014¿ guide wire cordis lab sample was introduced into the microcatheter and it advance smoothly until the microcatheter¿s distal tip and friction was felt when the guidewire was pass through kinked found on the microcatheter.However, the guide wire passed totally the microcatheter.After that an orbit mini complex cordis lab sample was introduced into the microcatheter and it advance smoothly until the microcatheter¿s distal tip and friction was felt when the orbit mini complex was pass through kinked found on the microcatheter.However the orbit mini complex passed the microcatheter.No dhr was conducted, since the lot number was not provided.The failure reported by the costumer inability to advance the coil was not confirmed.The failure experienced by the costumer and the damages found on the device could not be conclusively determined.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process; additionally inspections are in that prevents these kinds of damages leaving from the facility.Based on the information, and without the entire product not return for analysis, it is not possible to determine the cause of the event, additionally, it was reported that the devices were not damaged.Therefore, no corrective actions will be taken at this time.

• Brand Name: PROWLER SELECT MICROCATHETERS
• 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: 3621879
• MDR Text Key: 4135702
• Report Number: 1058196-2014-00040
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K021591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 606S1XXX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: MICRUSPHERE AND PRESIDIO MICROCOILS