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 12/25/2015

Event Type  malfunction  

Manufacturer Narrative

The product will not be returned for analysis however a device history record review is currently being conducted and the results are not yet available.No conclusion is made at this time.(b)(4).

Event Description

The contact from the facility reported that during coil embolization of the right internal iliac artery prior to the endovascular aneurysm repair a trufill pushable coil (catalog / lot # unknown) got stuck in the middle of the prowler select plus ((b)(4)).The patient's vessels were heavily torturous but not calcified.A gt guidewire (manufacturer unknown), an okay ((b)(4)), and enpower dcb / cable (lots unknown) were used for this procedure.It was reported the trufill coil, which was the first coil inserted, got stuck in the middle of the complaint prowler despite maintaining continuous flush.Thus, the prowler was withdrawn and replaced with a new one.The same coil went through another microcatheter (details unknown) without difficulty.The procedure was successfully completed without further issues or delay.There were no patient injury/complications.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu.No visible damage was noted on the product prior to the event.The complaint devices are not available for analysis.No further information is available.

Manufacturer Narrative

Review of dhr for lot 17217592 revealed no anomalies that can be related to the reported complaint.Based on the information, the event could not be confirmed.The product was not returned for analysis; however 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.

• 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: 5377465
• MDR Text Key: 36348551
• Report Number: 1058196-2016-00009
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• 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
• Report Date: 12/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Catalogue Number: 606S255FX
• Device Lot Number: 17217592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/04/2016
• Date Device Manufactured: 04/07/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 85 YR