MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PROWLER SELECT MICROCATHETERS; CATHETER, CONTINOUS FLUSH

Catalog Number 606S255X

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2016

Event Type  malfunction  

Manufacturer Narrative

This is one of two initial mdr submitted for this complaint with associated mfr# 3008264254-2016-00095 and 1226348-2016-00189.(b)(4).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

As reported by a health care professional, during coil embolization the enterprise stent (enc452212/ 10512792) could not be advanced via the mid shaft of a prowler microcatheter (606s255x/17197654).The stent was withdrawn with the microcatheter and new devices were used to complete the procedure.There were no damages noted on the complaint stent or the microcatheter prior to use or upon removal.An adequate flush maintained through the catheter and there was no difficulty tracking the catheter to the target site or excessive manipulation/torquing required prior to introduction of the stent.The vessels were not excessively tortuous.There was no report on the patient injury and there were no intra or post procedural complications related to the reported event or the device.Patient outcome was reported to be fine.It was initially reported that complaint product is available for return.

Manufacturer Narrative

This is one of two final mdr submitted for this complaint with associated mfr# 3008264254-2016-00095 and 1226348-2016-00189.A non-sterile prowler select plus 150/5cm microcatheter was received coiled inside unknown dispenser inside of a plastic bag.No damages were noted on the hub.The microcatheter was inspected and no damages were noted on it.However, residues dry of saline solution were found on the microcatheter body.The id of the microcatheter was measured and was found to be within specification.Hub id: 0.0215¿, specification: 0.021" minimum; distal id: 0.021¿¿, specification: 0.021" minimum.The functional analysis was performed and the received microcatheter was flushed out using a lab sample syringe (nipro), the water came out from the distal end of the device.A 0.018¿ guide wire cordis lab sample was introduced into the microcatheter and it advance smoothly until the microcatheter¿s distal tip without any difficulty.An enterprise lab sample was introduced into the micro-catheter and it can be advance through of the device until the distal end without any difficulty.The received enterprise under investigation (b)(4) could not be introduced into the microcatheter as the stent was received deployed.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.The failure reported by the customer as ¿catheter (body/shaft)- obstructed-in patient¿ was not confirmed.The device did not present any obvious indication of manufacturing defect or anomaly that could have contributed to the event.Neither the product analysis nor the dhr review suggests that the failure could be related to the manufacturing process.Therefore no corrective actions will be taken at this time.

• Brand Name: PROWLER SELECT MICROCATHETERS
• Type of Device: CATHETER, CONTINOUS FLUSH
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: karen anigbo ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 5088288374
• MDR Report Key: 6208915
• MDR Text Key: 63490252
• Report Number: 3008264254-2016-00095
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10886704028888
• UDI-Public: (01)10886704028888(17)180131(10)17197654
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 606S255X
• Device Lot Number: 17197654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1