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

Catalog Number 606S255FX

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2016

Event Type  malfunction  

Manufacturer Narrative

This is two of two initial mdr report being submitted for this complaint with associated mfr# 3008264254-2016-00081 and 1226348-2016-00168.(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.

Event Description

It was reported by a contact at the user facility that during the procedure strong resistance was felt when the physician advanced an enterprise stent (enf403000/10678110) through a prowler select plus microcatheter (606s255fx/17453680).The resistance was experienced in the proximal area of the microcatheter.The physician pulled the stent back out along with the microcatheter from the patients body safely and used a same like product to complete the procedure.There were no adverse events reported.The procedure was coiling of a side wall aneurysm at the internal carotid artery on (b)(6) 2016.There were no damages noted on the enterprise stent or the microcatheter prior to use or upon removal.An adequate continuous flush was maintained through the catheter.It was initially reported that the complaint product is not available for return.

Manufacturer Narrative

This is two of two final mdr report being submitted for this complaint with associated mfr# 3008264254-2016-00081 and 1226348-2016-00168.Based on the information, the reported event of the prowler catheter being obstructed 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.

Manufacturer Narrative

This is final mdr report being submitted for this complaint with associated mfr# 3008264254-2016-00081 and 1226348-2016-00168.Product returned.A non-sterile prowler sel plus 150/5 cm 45tip was received coiled inside of a plastic bag.The device was inspected and was found compressed/kinked at 66.5 cm from the distal end.The micro-catheter was inspected under microscope and it was found to be compressed/kinked.The ids from the micro-catheter were measured and were found to be within specification.Hub id.021¿ specification:.021¿ minimum; distal id.021¿ specification:.021¿ minimum.The received micro catheter was flushed using a lab sample syringe, after which a guide wire.018¿ lab sample was introduced into the micro catheter and was advanced until the micro catheter distal tip, resistance/friction was felt when the.018¿ guide wire lab sample was passed through the compressed/ kinked sections noted on the received device.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.The failure reported by the customer as ¿cbs ¿ obstructed¿ was not confirmed during the functional test.The failure experienced appears to be due to the compressed/kinked sections found on the received device.The compressed sections found on the body of the received micro catheter were apparently caused by excessive force applied on the devices but it could not be conclusively determined.Procedural factors appear to have contributed to this failure.No corrective action 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: 6106190
• MDR Text Key: 60031318
• Report Number: 3008264254-2016-00081
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10886704028857
• UDI-Public: (01)10886704028857(17)190228(10)17453680
• Combination Product (y/n): N
• Reporter Country Code: KN
• 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,Followup
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 606S255FX
• Device Lot Number: 17453680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ENTERPRISE STENT (ENF403000/10678110)