MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC RAPIDTRANSIT MICROCATHETERS; CES MICROCATHETERS (KRA)

Model Number N/A

Device Problems Obstruction of Flow (2423); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2015

Event Type  malfunction  

Event Description

The rapidtransit catheters (601251x/17118034 and 17133262) had trouble passing through a 5 french terumo guide catheter.Also the same catheters would not accept a boston scientific complex helical 0.018" pushable coil.The rapidtransit catheters eventually reached the target vessel site, a distal superior mesenteric artery aneurysm when the boston scientific coils were attempted to be advanced through them.The patient¿s vessels did not look calcified or tortuous.It is unknown if any devices kinked.When the rapidtransits were removed from the patient there were no damages on any part of the devices.The microcatheters were flushed before the coils were advanced.A hi-flo (details unknown) microcatheter was then advanced in place of the rapidtransit without a problem.Both catheters will be returned.There was no significant clinical delay to the procedure as a result of the issue.

Manufacturer Narrative

A non-sterile rapidtransit dual marker 150cm microcatheter was received coiled inside of a plastic bag.No damages were noted on the hub.Residues of blood dry were found in the luer of hub.The microcatheter was inspected and it was found kinked.The microcatheter was inspected under microscope and kinks were found on microcatheter body.The id and od from the microcatheter were measured and were found within specification according to document.The functional test was performed according.The rapidtransit microcatheter was introduced into a 0.058" androit guide catheter cordis lab sample and it advance smoothly until the androit distal tip without any difficulty.The received microcatheter was flushed using a lab sample syringe ((b)(4)) but water did not come out from the distal end of the device.A guide wire 0.018" lab sample was introduced into the microcatheter and it was stuck at 108cm from hub.The guide wire was removed from the device.The microcatheter was cut at 112cm from hub.After that the guidewire was inserted again and additional force was applied to it and residues of blood dry were expulsed from the cut section.The review of lot 17133262 revealed no anomalies that can be related to the reported complaint.The failure reported by the costumer that the catheter (body/shaft) obstructed the pushable coil was confirmed during the functional analysis.The failure reported by the customer as that it was difficult to advance the catheter through a guide catheter was not confirmed.The cause of the failure experienced by the customer appears was due to the kinks section found on the device, the cause of these defects could not be conclusively determined.However, neither the analysis nor the dhr suggest that the failure reported could related to the manufacturing process; additionally inspections are in place that prevents these kinds of damages leaving from the facility.Therefore no corrective actions will be taken at this time.This report is related to mfr report # 1058196-2015-00122.

Manufacturer Narrative

A non-sterile rapidtransit dual marker 150cm microcatheter was received coiled inside of a plastic bag.No damages were noted on the hub.Residues of blood dry were found in the luer of hub.The microcatheter was inspected and it was found kinked.The microcatheter was inspected under microscope and kinks were found on microcatheter body.The id and od from the microcatheter were measured and were found within specification according to document.The functional test was performed according.The rapidtransit microcatheter was introduced into a 0.058¿ androit guide catheter cordis lab sample and it advance smoothly until the androit distal tip without any difficulty.The received microcatheter was flushed using a lab sample syringe (635-002) but water did not come out from the distal end of the device.A guide wire 0.018¿ lab sample was introduced into the microcatheter and it was stuck at 108cm from hub.The guide wire was removed from the device.The microcatheter was cut at 112cm from hub.After that the guidewire was inserted again and additional force was applied to it and residues of blood dry were expulsed from the cut section.The review of lot 17133262 revealed no anomalies that can be related to the reported complaint.The failure reported by the costumer that the catheter (body/shaft) obstructed the pushable coil was confirmed during the functional analysis.The failure reported by the customer as that it was difficult to advance the catheter through a guide catheter was not confirmed.The cause of the failure experienced by the customer appears was due to the kinks section found on the device, the cause of these defects could not be conclusively determined.However, neither the analysis nor the dhr suggest that the failure reported could related to the manufacturing process; additionally inspections are in place that prevents these kinds of damages leaving from the facility.Therefore no corrective actions will be taken at this time.

• Brand Name: RAPIDTRANSIT MICROCATHETERS
• Type of Device: CES MICROCATHETERS (KRA)
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: duane durbin ; 14700 nw 57th court; miami lakes, FL 33014 ; 5088288310
• MDR Report Key: 4825569
• MDR Text Key: 16634800
• Report Number: 1058196-2015-00123
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• PMA/PMN Number: K972518
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 601251X
• Device Lot Number: 17133262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1