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 01/14/2015

Event Type  malfunction  

Event Description

It was reported by the hospital contact that during a stent assisted coil position surgery, the surgeon put the prowler select plus mc (b)(4) in place then advanced the stent (b)(4).The surgeon felt friction where the stent has not reached to the neck.The surgeon had to remove the stent and mc as a unit and changed new stent (details unknown) and mc (details unknown) to complete the surgery.There was no report on patient injury.The patient is male and (b)(6), had (b)(6).

Manufacturer Narrative

The product will not be returned for analysis and additional information will be submitted within 30 days of receipt.This is 1 of 2 reports associated with complaint (b)(4).Concomitant medical products and therapy dates: stent (b)(4), new stent (details unknown), new mc (details unknown).

Manufacturer Narrative

It was reported by the hospital contact that during a stent assisted coil position surgery, the surgeon put the prowler select plus mc (606s255x/16084669) in place then advanced the stent (enc452212/10380624).The surgeon felt friction where the stent has not reached to the neck.The surgeon had to remove the stent and mc as a unit and changed new stent (details unknown) and mc (details unknown) to complete the surgery.There was no report on patient injury.The patient is male and (b)(6), had (b)(6).It was unknown if there were any damages noted on the stent after use.There were no damages noted on the microcatheter after use.An adequate continuous flush was maintained through the microcatheter.There was no clinically significant delay in the procedure due to the event.The products will not be returned for analysis.Based on the information, the event was not confirmed.The product was not returned for analysis; however procedural factors may have contributed to the event.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.(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: 4508607
• MDR Text Key: 17626558
• Report Number: 1058196-2015-00033
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K021591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 606S255X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR