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

Catalog Number 606S255X

Device Problems Obstruction of Flow (2423); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This is one of one initial mdr report being submitted for this complaint.Date of event is not known.(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, the tip of the prowler select plus (606s255x/17160653) microcatheter was found to be rough and flattened during an endovascular coiling procedure.The flattening of the catheter was found during use on the patient when the competitor's stent was being attempted to be inserted but would not go through.The same stent was implanted using a competitor's catheter to complete the procedure.The procedure was stent assisted coiling of anterior communicating artery aneurysm.There were no intra or post procedural complications, delays or interventional treatments related to the device or the reported event.It is unknown if there were any damages to the shipping box, the outer product box or the inner product pouch.Product is available for analysis.

Manufacturer Narrative

This one of one final mdr report being submitted for this complaint.A non-sterile prowler select plus 150/5cm was received coiled inside of a plastic bag.The device was inspected and it was found compressed/kinked at 3.5, 6, 17 43 and 84cm from the distal end.The micro-catheter was inspected under microscope and it was found compressed/kinked.The id and od from the micro-catheter were measured and were found to be within specification.Hub id 0.021¿ specification: 0.21" minimum; distal id 0.021¿ specification: 0.21" minimum.The received micro catheter was flushed using a lab sample syringe, after which a guide wire 0.018¿ lab sample was introduced into the micro catheter and was advanced until the micro catheter distal tip, resistance/friction was felt when the guide wire 0.018¿ lab sample was passed through the compressed/ kinked sections noted on the received device.A review of the manufacturing documentation associated with this lot 17160653 presented no issues during the manufacturing process that can be related to the reported complaint.The reported failure of the catheter being obstructed was not confirmed during the functional test.Neither the analysis nor the dhr suggest that the failure reported by the customer could be related to the manufacturing process.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: 5825839
• MDR Text Key: 50539010
• Report Number: 3008264254-2016-00041
• 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: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 606S255X
• Device Lot Number: 17160653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1