MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PROWLER SELECT MICROCATHETERS; CES MICROCATHETERS (KRA)

Catalog Number 606S255X

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2015

Event Type  malfunction  

Manufacturer Narrative

The device is expected for analysis but not yet returned.No conclusions are made at this time.(b)(4).

Event Description

The contact at the facility reported that the enterprise stent (enf453712/10485322) could not be inserted into the prowler select plus (606s255x/17124635.) the physician used another same size prowler and enterprise.The procedure was successfully completed.

Manufacturer Narrative

Review of dhr for lot 17124635 revealed no anomalies that can be related to the reported complaint.The product has been returned for analysis but investigation is not yet complete.Additional information will be sent within 30 days of completion of investigation.

Manufacturer Narrative

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 at 7cm from the distal end.The micro-catheter was inspected under a microscope and was found compressed.The inner diameters of the microcatheter were measured and were found within specification.Hub id: 0.0215¿ specification: 0.21" minimum.Distal id: 0.0215¿ specification: 0.21" minimum the received microcatheter was flushed using a lab sample syringe (635-002), after that a guide wire 0.018¿ lab sample was introduced into the microcatheter and was advanced through of the device; friction was felt when the guide wire was passed through the compressed section found on the microcatheter.A review of the manufacturing documentation associated with this lot 17124635 presented no issues during the manufacturing process that can be related to the reported complaint.The reported event was not confirmed.The failure experienced by the customer appears was due to the compressed section noted on the received micro catheter.The compressed section found on the microcatheter was apparently caused by applying excessive force on the device but it could not be conclusively determined.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process and procedural factors appear to have contributed to this failure; additionally, inspections are in place that prevent these kinds of failures leaving from the facility.Therefore no corrective action will be taken at this time.

• Brand Name: PROWLER SELECT MICROCATHETERS
• Type of Device: CES MICROCATHETERS (KRA)
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: kimberly soter ; 14700 nw 57th court; miami lakes, FL 33014 ; 5089777396
• MDR Report Key: 5294004
• MDR Text Key: 33428358
• Report Number: 1058196-2015-00210
• Device Sequence Number: 1
• Product Code: KRA
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 606S255X
• Device Lot Number: 17124635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2016
• Date Device Manufactured: 11/11/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1