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

Catalog Number 606S155FX

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2015

Event Type  malfunction  

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.No conclusions are made at this time.

Event Description

The contact from the hospital reported that there were several issues with various coils when using codman coils during coil embolization of the left internal iliac artery aneurysm and thrombosis occurred during the procedure.A deltamaxx coil (cdx18226030/c31666) was stuck at the middle point of a prowler select lp es 45 (606s155fx/15771828) shaft when it was inserted, and both microcatheter and coil needed to be replaced.Other products (details unknown) were successfully used with the prowler select lp es prior to the encountered resistance.Two presidio coils's (pc418184630/c24604 and pc418195030/c20923) sheaths were split unexpectedly during advancement of the coils and then the coils were exposed at the distal point of a prowler select plus microcatheter (details unknown.) those coils were unable to be used.Severe resistance was experienced in the middle of the prowler select plus when advancing two other presidio coils (pc418083030/c20057 and pc418205030/c26420) and another deltamaxx coil (cdx18226030/c31666.) those coils could not be used.The prowler select plus remained in place at the target site.The doctor notes there was a thrombus in the blood vessel which could have caused some of the resistance during the procedure.The procedure was approached from the right femoral artery, the physician inserted a 4fr tempo guide sheath, a destination guide catheter (terumo, details unknown) and a prowler select plus (lot unknown).In addition, he opened a complaint prowler select lp es 45 and used both catheters during the procedure.The procedure was successfully completed after another 29 coils (details unknown) were implanted.There were no further issues or delay, and no patient injury/complications.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.No visible damage was noted on the product prior to the event.None of the devices were kinked prior to use however the resistance felt during use could have kinked some of the devices.The resistance could possibly have been caused by blocked blood vessels.At the time of initial contact the complaint products were available for analysis.No further information is available.

Manufacturer Narrative

A non-sterile prowler select lpes 45 deg tip was received coiled inside of a plastic bag.The device was inspected and residues of dry blood can be observed along of the device.No damages were noted on the body of the received micro-catheter (mc).The received mc was flushed using a lab sample syringe.After that, a guide wire.014¿¿ lab sample was introduced into the received mc and it advance until it was stuck at 67cm from the proximal end, the guide wire was removed.After that the mc was cut at 68cm from the proximal end and the lab sample guide wire was inserted again.Resistance was felt and additional force was applied on the device.Then a deltamaxx coil (cdx18226030/c31666) was exposed and was removed from the received micro catheter; after that the guide wire passed through the mc without any difficulty.The review of lot 15771828 revealed no anomalies that can be considered potentially related to the reported complaint.The failure reported by the customer as that the catheter obstructed the device was confirmed.However the obstructed found in the micro-catheter apparently was due to the coil found inside of the received device.Nevertheless this defect could not be related to the manufacturing process and procedural factors appear to have contributed to have this damage.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process.Additionally inspections are in place that prevent these 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: kimberly soter ; 14700 nw 57th court; miami lakes, FL 33014 ; 5089777396
• MDR Report Key: 5088878
• MDR Text Key: 26317295
• Report Number: 1058196-2015-00179
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• PMA/PMN Number: K021591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: 606S155FX
• Device Lot Number: 15771828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2015
• Date Device Manufactured: 12/12/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1