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 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

This is two of two initial mdr reports with associated mfr# 3008264254-2016-00093 and 1226348-2016-00188.(b)(4).The product will not be returned for analysis however a device history record review is currently being conducted and the results are not yet available.No conclusion is made at this time.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, during stent assisted coil embolization of right internal carotid artery aneurysm resistance was felt when an enterprise stent (enc452212/10540726) was being advanced through the mid-shaft of a prowler microcatheter (606s255x/ 17347907).The stent could not be deployed after being put in place.The stent was withdrawn with the microcatheter.A new enterprise stent (enc452212/10540726) and mc were used but the stent still could not be deployed.The stent was changed again to complete the procedure; only the stent was removed.There were no damages noted on the stent or the microcatheter prior to use or upon removal.An adequate flush was maintained through the catheter.There was no report on the patient injury and the patient outcome was reported to be fine.There were no intra or post procedural complications or surgical delays related to device or reported event.Patient was a (b)(6) male who had tuberculosis, hence the products were discarded and are not available for return.

Manufacturer Narrative

This is two of two final mdr reports with associated mfr# 3008264254-2016-00093 and 1226348-2016-00188.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 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: 6205106
• MDR Text Key: 63381590
• Report Number: 3008264254-2016-00093
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10886704028888
• UDI-Public: (01)10886704028888(17)180930(10)17347907
• 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: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 606S255X
• Device Lot Number: 17347907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR