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

Model Number 601251X

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2014

Event Type  malfunction  

Event Description

Prior to the procedure to treat the brain tumor, it was reported that the unspecified pushable coil (stryker) was stuck in about 10cm from the proximal end of the transit 2 (mc) microcatheter (b)(4).The physician was familiar of using a transit and a stryker¿s pushable coil in combination.The procedure was completed without further issues, and also there was no patient injury/complications reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all times.Prior to use, no defect (kink, bends, etc.) was noted on the product by visual inspection.Also no damages were reported on the concomitant devices after the event.The procedure was the coil embolization at the patient¿s occipital artery.The tortuosity level and the calcification level of the patient¿s vessels were both unknown.The patient¿s sex, dob and weight were also unknown.It was reported that an were used in combination with the complaint microcatheter for the above procedure.No further details of the concomitant devices are available.The complaint product will be returned together with the stuck coil for evaluation.No further information is available.

Manufacturer Narrative

The product is available for evaluation and testing, however the analysis has not been completed.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

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.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Prior to the procedure to treat the brain tumor, it was reported that the unspecified pushable coil (stryker) was stuck in about 10cm from the proximal end of the transit 2 (mc) microcatheter (601-251x/(b)(4)).The physician was familiar of using a transit and a stryker¿s pushable coil in combination.The procedure was completed without further issues, and also there was no patient injury/complications reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all times.Prior to use, no defect (kink, bends, etc.) was noted on the product by visual inspection.Also no damages were reported on the concomitant devices after the event.The procedure was the coil embolization at the patient¿s occipital artery.The tortuosity level and the calcification level of the patient¿s vessels were both unknown.The patient¿s sex, dob and weight were also unknown.No further details of the concomitant devices are available.The complaint product will be returned together with the stuck coil for evaluation.No further information is available a non-sterile rapid transit dual marker 150cm was received in two sections inside of a plastic bag.Residues of dry blood and dry saline solution can be observed on the device.The microcatheter was inspected under microscope and the edges of the cut sections show evidence that it was cut with an unknown tool; as well as residues of dry blood and dry saline solution can be observed on the device.The id from the micro-catheter was measured and was found within specification.The received micro-catheter was tried to flushing using a lab sample syringe (635-002) but was not possible since the water was not came out from the cut section found on the device: after that a guide wire.018¿ lab sample was introduced into the micro-catheter and it was stuck at 11cm from hub.The guide wire was removed from the device and residues of dry blood can be observed on it.The received micro-catheter was cut at 10.5cm from hub with the intention of remove the coil but it was not possible due to the micro-catheter was found saturated of dry saline solution.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.The failure reported by the costumer as ¿coil stuck in microcatheter was confirmed.The cause of the failure experienced by 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 and procedural factors appear to have contributed to have these damages.Additionally, inspections are in place to prevent these kinds of failures from leaving from the facility.Therefore, no corrective action will be taken at this time.This report is for complaint (b)(4).

Manufacturer Narrative

The product was received for analysis.Additional information will be submitted within 30 days of receipt.

• 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: 4187161
• MDR Text Key: 18296123
• Report Number: 1058196-2014-00266
• 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,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/02/2014

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 Expiration Date: 07/31/2015
• Device Model Number: 601251X
• Device Catalogue Number: 601251X
• Device Lot Number: 15688909
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2014
• Initial Date FDA Received: 10/20/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/16/2014; 11/20/2014; 11/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1