MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number ENF402300

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2017

Event Type  malfunction  

Manufacturer Narrative

This event met mdr reporting criteria on (b)(6) 2017 when it was reported that the event resulted in loss of cerebral target position.Phone (b)(6).Lot number unknown; (b)(4).Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, during treatment of the anterior cerebral artery (a1), there was strong resistance when advancing an enterprise device (catalog enf402300) through the prowler select plus microcatheter (606s255fx/ (b)(4)) and it was necessary to remove and replace both devices.It was reported that a continuous flush had been maintained through the microcatheter and there was no vessel tortuosity or calcification.The microcatheter did not appear damaged.There were no potential adverse events.

Manufacturer Narrative

Conclusion: as reported by a healthcare professional, during treatment of the anterior cerebral artery (a1), there was strong resistance when advancing an enterprise device (catalog enf402300) through the prowler select plus microcatheter (606s255fx/ 17483793) and it was necessary to remove and replace both devices.It was reported that a continuous flush had been maintained through the microcatheter and there was no vessel tortuosity or calcification.The microcatheter did not appear damaged.There were no potential adverse events.It was reported that the devices would be returned for analysis.A non-sterile prowler sel plus 150/5cm 45tip was received coiled inside of a pouch.The received device was inspected and it was found compressed at 5, and 19cm from the distal end.The received microcatheter was inspected under microscope and it was found compressed.The id from the microcatheter was measured and was found within specification.(hub id.021¿ specification:.021¿ minimum, distal id.021¿ specification:.021¿ minimum).The received microcatheter was tried to flush, but it was not possible.A guide wire.018¿¿ lab sample was introduced into the received microcatheter and it advanced until it was stuck inside of it.The guide wire was removed.After that the microcatheter was cut at 50.5cm from the proximal end and the lab sample guide wire was inserted again; resistance friction was felt and additional force was applied on the device and then residues of dry blood were ejected from the cut section.A review of the manufacturing documentation associated with this lot 17483793 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The enterprise was not returned for analysis.In addition, the lot number was not provided; therefore, a dhr could not be performed.The resistance was confirmed during the functional test of the prowler select plus.The event could not be confirmed for the enterprise stent without product return for analysis.The event appears was due to the compressed section noted on the received device.The cause of the compressed condition was apparently caused by applying excessive force on it, but it could not be conclusively determined.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process and procedural factors appear to have contributed to this failure.There is no current safety signal identified related to the reported events based on review of complaint histories for the devices.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.

• Brand Name: ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: joaquin kurz ; 325 paramount dr; raynham, MA 02767 ; 9497899383
• MDR Report Key: 7005865
• MDR Text Key: 92169561
• Report Number: 1226348-2017-00181
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENF402300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1