MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE STERLING¿; CATHETER, PERCUTANEOUS

Model Number H74939031304010

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 05/28/2015

Event Type  malfunction  

Event Description

It was reported the sterile packaging was not completely sealed.A 3.0mmx40mmx135cm sterling¿ balloon catheter was selected.The device was removed from the outer box which was sealed and when the sterile packing was opened, it was noted that the sterile packaging was not glued down appropriately.The device was not used in the patient and the procedure was completed using another of different device.No patient complications were reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a sterling balloon catheter received inside the opened product pouch.The seal of the product pouch was opened on the left side where the tyvek and poly material meet.The area of separation from tyvek and poly shows a residual of tyvek material which indicates a seal was present between the tyvek and the poly material.Uniform witness marks on the side seal give no visual or tactile indication of a possible seal defect.The product pouch was open, as-received in the cis lab; however, there was no evidence of a defective seal and no indication that the pouch was opened prior to shipment from bsc.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported the sterile packaging was not completely sealed.A 3.0mmx40mmx135cm sterling¿ balloon catheter was selected.The device was removed from the outer box which was sealed and when the sterile packing was opened, it was noted that the sterile packaging was not glued down appropriately.The device was not used in the patient and the procedure was completed using another of different device.No patient complications were reported.

• Brand Name: STERLING¿
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4860141
• MDR Text Key: 22158320
• Report Number: 2134265-2015-03887
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: H74939031304010
• Device Catalogue Number: 39031-30401
• Device Lot Number: 17673413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2015
• 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