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

Model Number N/A

Device Problems Collapse (1099); Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/27/2015

Event Type  malfunction  

Event Description

The contact at the hospital reported that when the operator tried to advance the enterprise stent (enf452800/10398723) through the hub of the microcatheter (details unknown), he felt resistance and was not able to advance the stent.It was confirmed that the introducer was fully seated and secured in the catheter hub during introduction of the device into the catheter.The enterprise was removed.When it was removed there were no damages on any part of the device.Another enterprise stent (details unknown) passed through the same microcatheter.An adequate continuous flush was maintained through the catheter.There was no reported patient impact associated with the complaint.The device did not kink or bend at any time prior to the resistance/friction.The concomitant devices did not kink or bend at any time.There was no significant delay to the procedure as a result of the issue.At the time of initial contact, the product was available for return.During product analysis, the investigator discovered that the microcatheter was compressed at the distal tip.

Manufacturer Narrative

No sterile lot number information was available thus no dhr could be performed.A non-sterile prowler select plus microcatheter was received coiled inside of a plastic bag.In addition, the involved enterprise device was observed separated from the microcatheter.The stent was found deployed inside the microcatheter.No damages were noted on the hub.The id band was found damaged.The microcatheter was inspected and a compressed section was found.The device was inspected under microscope; compressed sections were noted.The id from the microcatheter was measured and was found within specification.The functional test was performed.The prowler selplus microcatheter was flushed out using a lab sample syringe (nipro) and water came out from the distal end of the device.A 0.018¿ guide wire cordis lab sample was introduced into the microcatheter and severe resistance was felt when guide wire lab sample was passed through of compressed sections found on the device.However, the guide wire passed through the microcatheter.The enterprise lab sample cannot be inserted through the microcatheter due to the compressed sections found on the distal end tip.The failure reported by the customer that the microcatheter obstructed the stent was not confirmed during the functional test.An additional failure discovered during analysis that the brite tip/distal tip was compressed/crushed was discovered during the visual analysis.The cause of the failure experienced by the customer appears was due to the compressed section found on the device.The cause of these defects could not be conclusively determined however the analysis suggests that the failure reported could not be related to the manufacturing process.Therefore no corrective actions will be taken at this time.This report is related to mfr report reference # 1058196-2015-00114.

• 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: duane durbin ; 14700 nw 57th court; miami lakes, FL 33014 ; 5088288310
• MDR Report Key: 4828512
• MDR Text Key: 5841839
• Report Number: 1058196-2015-00113
• 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: Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 606SXXX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2015
• Date Manufacturer Received: 06/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1