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

Catalog Number ZISV6-35-125-6.0-120-PTX

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information pertaining to as follows: (b)(4).Importer site establishment registration number: (b)(4).Pma/510(k) # p100022/s001.Problem statement ¿after opening the outer (foil) packaging, the nurse unit manager noticed a cut on the sterile packaging.¿ device evaluation the zisv6-35-125-6.0-120-ptx device involved in this complaint has not yet been returned for evaluation.With the information provided, a document based investigation was conducted.The customer was contacted to arrange return of the complaint device.The investigation will be updated once the device has been returned and evaluated.The customer provided an image of the device packaging.The image shows a tear in the inner tyvek pouch.Complaint is confirmed as the failure was verified in the image provided by the customer.Possible causes for this occurrence could include the handling of the device as the device packaging was opened, with the customer not moving the inner packaging away from the tear notches of the foil pouch.However, as the device has not yet been returned, and the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.From the product instructions for use: do not use the product if there is doubt as to whether the product is sterile." document review prior to distribution, all zisv6 (zilver ptx thumbwheel) devices are subject to visual inspection and functional checks to ensure device integrity as per fqc.A review of the relevant manufacturing records 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 this lot number.It may be noted that the failure mode of "foil pouch & tyvek pouch opened simultaneously" has been provisionally assigned.The final failure mode will be confirmed following device return and evaluation.Summary complaint is confirmed as the failure was verified in the image provided by the customer.The risk will be assessed for this complaint when the device is returned and evaluated, and once completed the investigation will be updated with the risk details.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The incident occurred as the device packaging was opened, prior to patient contact.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

After opening the outer (foil) packaging, the nurse unit manager noticed a cut on the sterile packaging.

Event Description

This follow up report is being submitted to update the investigation with the device return.After opening the outer (foil) packaging, the nurse unit manager noticed a cut on the sterile packaging.

Manufacturer Narrative

Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).Pma/510(k) # p100022/s001.Problem statement ¿after opening the outer (foil) packaging, the nurse unit manager noticed a cut on the sterile packaging.¿ device evaluation the zisv6-35-125-6.0-120-ptx device 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.The customer provided an image of the device packaging.The image shows a tear in the inner tyvek pouch.The device related to this occurrence underwent a laboratory evaluation on the 31st may 2018.On evaluation of the returned device, it was noted that there was evidence of tearing in the tyvek pouch.The factory and vendor seals on the tyvek pouch were still intact.The foil pouch was not evaluated.Complaint is confirmed as the failure was verified in the image provided by the customer, and from the laboratory evaluation.Possible causes for this occurrence could include the handling of the device as the device packaging was opened, with the customer not moving the inner packaging away from the tear notches of the foil pouch.However, as the circumstances of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.From the product instructions for use: do not use the product if there is doubt as to whether the product is sterile." document review prior to distribution, all zisv6 (zilver ptx thumbwheel) devices are subject to visual inspection and functional checks to ensure device integrity as per fqc.A review of the relevant manufacturing records 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 this lot number.Summary complaint is confirmed as the failure was verified in the image provided by the customer, and from the laboratory evaluation.The risk was determined to be low (category iii).According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The incident occurred as the device packaging was opened, prior to patient contact.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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; national technology park; limerick
• MDR Report Key: 7494436
• MDR Text Key: 108166997
• Report Number: 3001845648-2018-00207
• Device Sequence Number: 1
• Product Code: NIU
• UDI-Device Identifier: 10827002352855
• UDI-Public: (01)10827002352855(17)181102(10)C1332483
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2018
• Device Catalogue Number: ZISV6-35-125-6.0-120-PTX
• Device Lot Number: C1332483
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/08/2018
• Event Location: Hospital
• Date Manufacturer Received: 04/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1