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

Catalog Number UNKENTERPRISEENF

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that the device would be returned for analysis; however, the device has not yet been returned.Udi: unknown part number, all attempts to obtain product were unsuccessful, udi unavailable.Additional information will be submitted within 30 days of receipt.This is 1 of 2 mdr reports being sent for this complaint with referenced numbers of 3008264254-2017-00054 and 1226348-2017-00056.

Event Description

As reported by a healthcare professional, when the surgeon used the prowler select plus catheter (606s255fx/ 17606216), he felt the proximal resistance during inserting enterprise stent (catalog/lot unk).The surgeon used another microcatheter, and the procedure was successfully completed.A continuous flush had been maintained through the microcatheter.Neither the microcatheter nor the enterprise appeared damaged in any way and the stent did not prematurely deploy during the procedure.There was no patient injury or procedure delay.It was reported that product would be returned for analysis; however, product has not yet been returned.

Manufacturer Narrative

Initial reporter updated.(b)(6).

Manufacturer Narrative

Initial reporter updated (phone # listed here as the format will not be accepted) (b)(6).

Manufacturer Narrative

Initial reporter updated (phone # listed here as the format will not be accepted) (b)(6).

Manufacturer Narrative

The enterprise stent was not returned for analysis.In addition, the lot number was not provided.Conclusion: as reported by a healthcare professional, when the surgeon used the prowler select plus catheter (606s255fx/ 17606216), he felt the proximal resistance during inserting enterprise stent (catalog/lot unk).The surgeon used another microcatheter, and the procedure was successfully completed.A continuous flush had been maintained through the microcatheter.Neither the microcatheter nor the enterprise appeared damaged in any way and the stent did not prematurely deploy during the procedure.There was no patient injury or procedure delay.A non-sterile prowler sel plus 150/5cm 45tip microcatheter was received coiled inside of a plastic bag.No damages were noted on the hub.The microcatheter was inspected and compressed sections were found at.3,.8 mm and 2.8cm from the distal end tip.The microcatheter body was inspected under vision system; compressed sections were found on distal section of the microcatheter.The id from the microcatheter was measured and it was found within specification.The functional test was performed.The received microcatheter was flushed out using a lab sample syringe.The water came out from the distal end of the device.A 0.018¿ guide wire lab sample was introduced into the microcatheter and it advance smoothly until the microcatheter¿s distal tip severe resistance was felt when it passed through the compressed sections.An enterprise lab sample was introduced and it advance smoothly until the microcatheter¿s distal tip, but was stuck in compressed sections found on distal end tip.The dhr review of the manufacturing documentation associated with this lot 17606216 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The enterprise used for the procedure was not available for analysis.In addition, the lot number was not available; therefore, a dhr could not be performed.The resistance/friction was confirmed based on the analysis of the prowler select plus.Since the enterprise device was not returned for analysis, the event could not be confirmed for this device.The cause of the failure appears was due to the compressed sections found on the device; however, 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 leaving from the facility.Therefore, no corrective actions will be taken at this time.This is 1 of 2 mdr reports being sent for this complaint with referenced numbers of 3008264254-2017-00054 and 1226348-2017-00056.

• 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: karen anigbo ; 325 paramount dr; raynham, MA 02767 ; 5088288374
• MDR Report Key: 6578088
• MDR Text Key: 75606272
• Report Number: 1226348-2017-00056
• 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,Followup,Followup,Followup
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISEENF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2017
• 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