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

Catalog Number 606XXX

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2014

Event Type  malfunction  

Event Description

It was reported by the hospital contact that the enterprise stent (enf452200/10295706) was stuck in the prowler microcatheter (details unknown) when the physician pulled out to deploy through the vessel.So he pulled out the prowler microcatheter with the stuck enterprise stent all together.The enterprise stent will be returned for analysis.

Manufacturer Narrative

It was reported by the hospital contact that the enterprise stent (enf452200/10295706) was stuck in the prowler microcatheter (details unknown) when the physician pulled out to deploy through the vessel.So he pulled out the prowler microcatheter with the stuck enterprise stent all together.The enterprise stent will be returned for analysis.(b)(4).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 lot number was not provided therefore a review of the manufacturing documentation could not be performed.No corrective actions will be taken at this time.This is an initial/final report.This is 1 of 2 reports associated with (b)(4).Concomitant medical products and therapy dates: enterprise stent (enf452200/10295706).

Manufacturer Narrative

Conclusion updated with product analysis: it was reported by the hospital contact that the enterprise stent (enf452200/(b)(4)) was stuck in the prowler microcatheter (606s255fx/(b)(4)) when the physician pulled out to deploy through the vessel.So he pulled out the prowler microcatheter with the stuck enterprise stent all together.The products will be returned for analysis.There was no clinically significant delay in the procedure due to the event.There were no damages noted on the stent or microcatheter after use.An adequate continuous flush was maintained through the microcatheter.The target vessel was mca.A non-sterile prowler select plus was received coiled inside of a plastic bag.In addition, the involved delivery wire device was received separated of microcatheter.No damages were noted on the hub.The microcatheter was inspected and it was found compressed sections.The microcatheter was inspected under microscope and compressed sections were found on distal end tip.The id from the microcatheter was measured and was found within specification.The functional test was performed.The received microcatheter was tried to flushing using a lab sample syringe (635-002) but was not possible since the water was not came out from the distal end of the device; a guide wire.018¿ lab sample was introduced into the microcatheter and it was stuck at 5cm from hub and when picking the guide wire, the stent started to come out in luer hub.The stent was removed of the hub of device.A guide wire.018¿ lab sample was introduced into the microcatheter anew and it was stuck at 126cm.The guide wire was removed from the device.Same guide wire.018¿ lab sample was introduced into the microcatheter for distal end tip and it was stuck at 29 cm.The microcatheter was cut at 127.Cm from the proximal end of hub.After that guide wire.018 was inserted and additional force was applied to it and residues of dry saline solution were expulsed from the cut section.Review of lot 15394947 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The failure reported by the customer as ¿catheter (body/shaft) ¿ obstructed in patient¿ was confirmed during the functional 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, neither the analysis nor the dhr suggest that the failure reported could relate to the manufacturing process; additionally inspections are in place that prevents these kinds of damages from leaving the facility.Therefore no corrective actions will be taken at this time.This is 1 of 2 reports associated with (b)(4).

• Brand Name: UNKNOWN PROWLER CATALOG NUMBER
• 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: 4419144
• MDR Text Key: 15910746
• Report Number: 1058196-2015-00010
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 606XXX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1