MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER PTX DRUG-ELUTING PERIPHERAL STENT; NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Catalog Number ZISV6-35-125-5.0-120-PTX

Device Problem Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k) # p100022/s014.The zisv6-35-125-5.0-120-ptx device of lot number c1304772 involved in this complaint was returned for evaluation, with the original packaging.The packaging was open on receipt.With the information provided, a physical examination and document based investigation was conducted.From customer testimony, when the surgical assistant opened the outer packaging, the inner packaging open unexpectedly.The product become non-sterile as the inner packaging opened outside the sterile field.On evaluation of the returned device, it was observed that there was no evidence that the tyvek inner pouch was sealed into the foil pouch.It was noted that the foil pouch was opened at the supplier sealed end of the pouch, and opposite to the cook sealed end.Details and images of the returned device were provided to the manufacturing department for evaluation.The manufacturing steps for this product involves the foil pouch being received from the supplier with one end of the pouch pre-sealed.The tyvek pouch is sealed, and the tyvek pouch is placed in the open end of the foil pouch, and the foil pouch is then sealed at the open end.The manufacturing department confirmed that the customer opened the packaging at the supplier seal.Therefore, there is no possibility that the pouches were sealed together at cook, and therefore there was no manufacturing defect.The customer complaint is confirmed as the outer foil and inner tyvek pouches were torn open.Possible causes for this occurrence could include the handling of the device during the opening of the foil pouch.However, as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.Prior to distribution, all zisv6 (zilver ptx thumbwheel) devices are subject to visual inspection and functional checks to ensure device integrity.A review of the relevant manufacturing records (c1304772) did not reveal any discrepancies which could have contributed to this complaint issue.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1304772.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The incident occurred during device preparation and before patient contact.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

Event Description

The inner and middle pouch of the product package were glued together.While opening the outer pouch the inner one also was opened.In this unexpected situation the product became unsterile touched by the nurse.

• Brand Name: ZILVER PTX DRUG-ELUTING PERIPHERAL STENT
• Type of Device: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer Contact: tracy o'sullivan ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 6621245
• MDR Text Key: 76986804
• Report Number: 3001845648-2017-00213
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002352770
• UDI-Public: (01)10827002352770(17)181103(10)C1304772
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZISV6-35-125-5.0-120-PTX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/08/2017
• Event Location: Hospital
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1