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

Catalog Number 606S255FX

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2011

Event Type  malfunction  

Event Description

The event reported via voluntary medwatch report indicated that during an attempt to use an enterprise (enf451214/01428609) stent patient's aneurysm, but as advancing the stent into the prowler select microcatheter (606s266fx/lot unk), the device was stuck.In attempting to pull out the device, it deployed out of the catheter too far to recapture.Second try at new stent was successful.Then, attempt to place a presidio microcoil (pc410051730/g12947) and it got stuck in the catheter as well.It too was pulled out and another coil placed successfully.No further information was available.

Manufacturer Narrative

The account and contact information was not provided in the maude database, therefore it was not included in this report.The device was not returned for analysis, and the lot was not provided to conduct dhr review.The device was not returned for analysis; therefore, the reported event could not be confirmed.With the available information it is not possible to determine the cause of the event, it is possible that procedural factors contributed to the events.Additionally, no dhr review could be performed, since the lot was not provide.Additionally inspections are in place that prevent this kind of failures leaving from the facility.Therefore, no corrective action will be taken at this time., this is one of three products associated with this event and complaint #(b)(4).(b)(4).

• 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: 4739449
• MDR Text Key: 5772675
• Report Number: 1058196-2015-00091
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 606S255FX
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1