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

Model Number N/A

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2015

Event Type  malfunction  

Event Description

The contact at the hospital reported that during stent-assisted coil position surgery of a posterior communicating artery (pcom) the presidio coil (pc410062630/ c24469) stretched after withdrawing into the prowler select plus microcatheter (606s255x/16060748) and repositioning.The aneurysm size was 5.2*6.3 mm.The neck width was 4.3 mm.The jailing technique was used to position the coil.After positioning the coil, the surgeon noted the shape was not satisfactory in the aneurysm.He withdrew the coil into microcatheter immediately and began to position it again after adjusting.It was noted the coil had partly stretched.The surgeon had to change to another coil.The coil and microcatheter were removed together.It was also noted that the stent (details unknown) could not be deployed and got stuck in the microcatheter.When the surgeon removed the microcatheter it was found that the tip of the microcatheter was compressed.He changed to another microcatheter to complete.There was no reported patient injury.At the time of the initial contact the products were not available for return.There was no significant clinical delay to the procedure as a result of the issue.An adequate continuous flush was maintained through the microcatheter at all times.There was no resistance between the guidewire and microcatheter when accessing the target site.There was no resistance when the coil was advanced/repositioned/withdrawn.

Manufacturer Narrative

Concomitant devices: presidio coil (pc410062630/ c24469); stent (details unknown).The product will not be returned.The dhr will be reviewed and additional information and conclusions will be provided within 30 days.

Manufacturer Narrative

Review of the dhr associated with the prowler select plus (lot 16060748) revealed no issues that were considered potentially related to the reported complaint.Based on the information, the event could not be confirmed.The product was not returned for analysis; however, a review of the manufacturing documentation associated with the lots presented no issues during the manufacturing or inspection processes that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.

Manufacturer Narrative

A non-sterile prowler select plus 150/5cm was received coiled inside of a plastic bag.The device was inspected and it was found compressed in the body.Residues of dry blood can be observed on the device.The micro-catheter was inspected under microscope and it was found compressed.The id and od from the micro-catheter were measured and were found within specification.The received microcatheter was flushed using a lab sample syringe (635-002), after that a guide wire.018¿ lab sample was introduced into the microcatheter and it can be advance through of the device; friction was felt when the guide wire was passed through the compressed section found on the microcatheter.The review of lot 16060748 revealed no anomalies that can be related to the reported complaint.The event reported that the ¿catheter body shaft ¿ obstructed¿ was not confirmed during the functional test.The event reported as ¿brite tip/distal tip - compressed/crushed" was not confirmed during the microscopic analysis (the compressed sections found in the micro catheter are not located at the distal tip section.) 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 this failure; additionally inspections are in place that prevents this kind of failures leaving from the facility.Therefore no corrective action will be taken at this time.

• Brand Name: PROWLER SELECT 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: 4665841
• MDR Text Key: 5621794
• Report Number: 1058196-2015-00075
• 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,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 606S255X
• Device Lot Number: 16060748
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2015
• Date Device Manufactured: 02/04/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1