MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY NEPHROMAX¿; CATHETER, NEPHROSTOMY

Model Number M0062101180

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a nephromax balloon dilator kit was used during a urology procedure performed on an unknown date.According to the complainant, during preparation, the hair was found inside of the intact sterile packaging.There were no obvious indications that the device packaging or the shipping container was damaged or compromised.The procedure was completed with another nephromax balloon dilator kit.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

Visual examination of the returned device revealed that the tray had been opened but found no evidence that the device had been used.The device was placed inside the packaging tray and a hair was taped to the tray.The hair was examined and noted that it was measuring 7 mm in length.Therefore, the condition of the returned device confirms the reported event.As the device was received with the packaging having already been opened, the root cause as to where and when the hair came in contact with the packaging is undetermined.Given the event description and condition of the returned device, there isn't enough information to determine a probable root cause.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.(b)(4).

Event Description

It was reported to boston scientific corporation that a nephromax balloon dilator kit was used during a urology procedure performed on an unknown date.According to the complainant, during preparation, the hair was found inside of the intact sterile packaging.There were no obvious indications that the device packaging or the shipping container was damaged or compromised.The procedure was completed with another nephromax balloon dilator kit.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.

• Brand Name: NEPHROMAX¿
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5950894
• MDR Text Key: 54761156
• Report Number: 3005099803-2016-02691
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952968
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: M0062101180
• Device Catalogue Number: 210-118
• Device Lot Number: 19430735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2016
• Initial Date FDA Received: 09/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2016
• 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