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 01/16/2017

Event Type  malfunction  

Manufacturer Narrative

This is two of two initial mdr report for this complaint with associated mfr# 3008264254-2017-00017 and 1226348-2017-00014.(b)(4).The product is expected to be returned for analysis, however it has not been received.Additional information will be submitted within 30 days of receipt.No conclusions are made at this time.

Event Description

It was reported by the health care professional that resistance was experienced during the procedure when the surgeon was using an enterprise 2 stent and a prowler catheter.The patient had stenosis of the left carotid interna; enterprise 2 stent was used to open the vessel.The stent was 60% released and the surgeon was not satisfied with the position of the stent and wanted to recapture the stent; however felt massive resistance when he tried to recapture the stent into the microcatheter.He could recapture the stent by moving the micro catheter over the stent.When attempting to deploy the stent again, it was discovered that the stent got stuck in the catheter and could not be pushed forward.Both the stent and the prowler mc were removed from the patient.The procedure was completed with same like product with no significant delay.There were no issues with release of the new product.There were no damages noted on the complaint enterprise stent or the prowler catheter prior to use or upon removal.There were no adverse consequences to the patient due to the reported event.The complaint stent and the prowler catheter will be sent back for investigation.

Manufacturer Narrative

This is two of two final mdr report for this complaint with associated mfr# 3008264254-2017-00017 and 1226348-2017-00014.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 this lot 17551775 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.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: 6327817
• MDR Text Key: 67331278
• Report Number: 3008264254-2017-00017
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10886704028888
• UDI-Public: (01)10886704028888(17)190731(10)17551775
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 606S255X
• Device Lot Number: 17551775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR