MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION, NAMIC TECHNOLOGY CT NAVILYST MEDICAL ; CONVENIENCE KIT

Catalog Number H749606918541

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/05/2015

Event Type  malfunction  

Event Description

As reported by navilyst medical's distributor in (b)(6), a convenience kit was noted to have a small hole in the pouch, thereby compromising sterility.The kit was never set to an end user, and has been returned to navility medical.

Manufacturer Narrative

The reported device has been returned to navilyst medical.Upon completion of the investigation, a supplemental medwatch will be submitted.

Manufacturer Narrative

A review of the device history records was performed for the reported packaging lot for any deviations related to the reported defect of the complaint.The review confirms that the lot met all material, assembly and performance specifications.The angiodynamics september 2015 complaint report was reviewed for the product family of convenience kits and the failure mode, "pouch torn/holes (sterile)." no adverse trends were identified.The returned sample was visually inspected and the hole in the pouch was confirmed.Angiodynamics packaging engineering determined that the likely root cause of the hole was a result of the manifold device handle pushing outward against the tyvek.The review also noted that the pouch size is appropriate for the devices within the kit and the number of pouches per inner box is also appropriate.The returned sample had a (b)(6) label on the pouch.As part of the receiving process at (b)(6) all pouches are removed from their inner boxes and a (b)(6) label (in (b)(4)) is applied to each pouch and inner box.Additional handling may occur if product is 100 percent visually inspected.The pouches are then re-boxed into the inner boxes by the (b)(6) warehouse employees.The cause of the hole in the tyvek of the pouch was likely the result of the handle of the manifold device in the pouch.The ultimate root cause of how the handle punctured the tyvek, however, cannot be determined.Potential factors contributing to the damage include: handling of the pouches as they are placed in the inner boxes; handling during transit to (b)(6) warehouse; handling at (b)(6) during the labeling/inspection and re-boxing process.All pouches are 100 percent inspected per angiodynamics procedures during the sealing and final boxes processes.The directions for use (dfu) included with the kits contain the following warning: "contents supplied sterile using an ethylene oxide (eo) process.Do not use if sterile barrier is damaged." all packaging employees have been made aware of this complaint in order to improve their awareness of the defect and to improve the probability of identifying the defect in the future.

• Brand Name: NAVILYST MEDICAL
• Type of Device: CONVENIENCE KIT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION, NAMIC TECHNOLOGY CT; glens falls NY
• Manufacturer (Section G): NAVILYSTE MEDICAL; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: michael duerr ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424571
• MDR Report Key: 4507228
• MDR Text Key: 5528693
• Report Number: 1317056-2015-00029
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: H749606918541
• Device Lot Number: 4817381
• Other Device ID Number: CONVENIENCE KIT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/27/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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