MAUDE Adverse Event Report: CORDIS NEUROVASCULAR, INC. ENTERPRISE 4.5MM DIA 22MM LGTH; CNV ENTERPRISE SES

Catalog Number ENF452212

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2015

Event Type  malfunction  

Event Description

The enterprise (catalog/lot unk) did not advance through the prowler select plus (606s255fx/ 17033056).The physician changed both products, and the procedure was successfully completed.The devices will be returned for analysis.

Manufacturer Narrative

Patient age, gender, weight and target vessel were not reported.The catalog and lot number of the device were not provided.It is anticipated that the device will be returned for analysis; however, the device has not yet been returned.Udi: unknown part number, all 3 attempts to obtain product were unsuccessful, udi unavailable.Additional information will be submitted within 30 days of receipt.This is 1 of 2 mdrs submitted for this complaint with associated report numbers of 1058196-2015-00107 and 1058196-2015-00106.

Manufacturer Narrative

Additional information that was available on 4/20/2015: the enterprise catalog/lot numbers are enf452212/10424435.There were no patient adverse events.Additional information will be submitted within 30 days of receipt.This is 1 of 2 mdrs submitted for this complaint with associated report numbers of 1058196-2015-00107 and 1058196-2015-00106.(b)(4).

Manufacturer Narrative

Product returned for analysis on 5/20/2015.Complaint conclusion: the enterprise (enf452212/10424435) did not advance through prowler select plus (606s255fx/ 17033056).The physician changed both products, and the procedure was successfully completed.There were no adverse events associated with the event.No additional information could be obtained.One non-sterile enterprise was received inside of a plastic bag.The delivery wire presented no visual damage.The enterprise stent was received on it original position into the introducer tube.The involved microcatheter ((b)(4)) presented no visual damaged.No visual anomalies were observed on the received units.The functional analysis was performed.The enterprise system was able to go through the mc without any resistance friction.The stent was inspected under a microscope and presented no damaged.Lake region medical reviewed the device history records relative to the manufacturing, inspecting and packaging of lot 10424435.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The reported resistance between the prowler and enterprise was not confirmed during functional testing.The cause of the failure experienced by the costumer could not be conclusively determined.Procedural/handling factors appear to have impacted on the failure experienced by the customer.The devices did not present any obvious indication of manufacturing defect or anomaly that could contributed to the event as reported.Neither the product analysis nor the dhr review suggests that the failure could be related to the enterprise manufacturing process; therefore, no corrective action will be taken at this time.This is 1 of 2 mdrs submitted for this complaint with associated report numbers of 1058196-2015-00107 and 1058196-2015-00106.

• Brand Name: ENTERPRISE 4.5MM DIA 22MM LGTH
• Type of Device: CNV ENTERPRISE SES
• Manufacturer (Section D): CORDIS NEUROVASCULAR, INC.; 14700 nw 57th court; miami lakes FL
• Manufacturer Contact: duane durbin ; 14700 nw 57th court; miami lakes, FL 33014 ; 5088288310
• MDR Report Key: 4771620
• MDR Text Key: 5947416
• Report Number: 1058196-2015-00106
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: ENF452212
• Device Lot Number: 10424435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PROWLER SELECT PLUS (606S255FX/ 17033056)