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 12/12/2014

Event Type  malfunction  

Event Description

The contact at the facility reported that during the stent-assisted coil embolization of an unruptured aneurysm at the patient¿s left intracranial vertebral artery, an enterprise vrd (enc452812/10219161) could not be delivered to the target site through a prowler select plus (606-s255x/16038839).The procedure was approached from the right femoral artery.The patient¿s vessels were not tortuous but moderately calcified.It was reported that an unspecified 7fr-10 sheath introducer, a radifocus gt wire (terumo, type unknown), a fubuki (asahi intecc, 6fr 100cm type), a headway (terumo, 90°shape type), and an okay (goodman, type unknown) were also used for the above procedure.The jailed-technique was conducted for this procedure.It was reported that the physician was unable to deliver the complaint vrd to the target lesion site due to experiencing a severe resistance at 5cm from the hub of the complaint prowler upon the insertion.The enterprise vrd was safely removed from the patient with the prowler.The aforementioned headway was inserted, and the physician was able to deploy another vrd without experiencing an issue.The procedure was successfully completed without further issues or delay.There were no patient injury/complications the complaint products were new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all times.No visible defect (kink, bends, etc.) were noted on the devices prior to and the after the events.No unintended detachment of the vrd was observed in the vessel or in the microcatheter.The prowler has already been safely disposed, therefore only the complaint vrd will be available for analysis.No further information is available.

Manufacturer Narrative

Concomitant devices: 7fr-10 sheath introducer; radifocus gt guidewire (terumo, type unknown); fubuki guide catheter (asahi intecc, 6fr 100cm type); headway microcatheter (terumo, 90°shape type); okay y connector (goodman, type unknown); enterprise stent (enc452812/10219161).The product will not be returned for analysis and additional information will be submitted within 30 days of receipt.The device history record review is not yet complete.No conclusions are made at this time.This complaint is related to mfr.Report # 1058196-2015-00003.

Manufacturer Narrative

Review of dhr for lot 16038839 revealed no issues that could be considered related to the reported complaint.Based on the information, the event could not be confirmed.The product was not returned for analysis and a device history record review cannot be completed because the lot for the product is unknown.Since the event could not be confirmed and there is no evidence of a manufacturing-related malfunction, 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: duane durbin ; 14700 nw 57th court; miami lakes, FL 33014 ; 5088288310
• MDR Report Key: 4394047
• MDR Text Key: 5301618
• Report Number: 1058196-2015-00004
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: 606S255X
• Device Lot Number: 16038839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2015
• Date Device Manufactured: 01/07/2014
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 79 YR