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 07/21/2016

Event Type  malfunction  

Manufacturer Narrative

This is two of two initial mdr report being submitted for this complaint with the associated mfr# 1226348-2016-00129.(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 health care professional, during the procedure, an enterprise stent was getting stuck at the distal end of the prowler select plus catheter (606s255x/17199571).The physician was not able to deploy the stent; the stent deployed in the catheter hub when the physician was resheathing the stent.The procedure was abandoned.It is unknown if the reported event caused any delays or adverse events.No difficulty was reported tracking the catheter to the target site or excessive torquing required prior to the introduction of the stent.An adequate continuous flush was maintained through the catheter.Procedure was endovascular coiling at the middle cerebral artery and the patient's vessels were reported to be of medium tortuousity; no further patient or procedure information was provided.Prowler select plus catheter is not available for return.

Manufacturer Narrative

This is two of two final mdr reports being submitted for this complaint with associated mfr report# 1226348-2016-00129.The reported event of obstruction of the prowler select plus catheter 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: 5872641
• MDR Text Key: 52006465
• Report Number: 3008264254-2016-00047
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2016
• 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: 17199571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1