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

Model Number M0062101420

Device Problem Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a nephromax balloon catheter was unpacked on an unknown date.According to the complainant, during unpacking, when they opened the outer box, the sterile packaging of the device was already opened.There was no visible damage noted on the outer box.Reportedly, this device was not used in a patient or procedure.

Manufacturer Narrative

Investigation results a visual examination of the complaint device revealed that the outer pouch was opened on its chevron (vendor) seal side.It was also noted that the inner pouch was torn open on the chevron (vendor) seal side.This tear extended down each side of the pouch, indicating that the pouch had been torn open.Inside the inner pouch was the tray containing the device.This tray was removed and an examination found no damage to the tray.The device was coiled correctly inside the tray and there was no evidence of any device use.The noted defect likely occurred due to handling of the device or portion of the device without direct patient contact either during shipping, unpacking or preparation of the device for the procedure.This could have led to the gauge receiving a shock causing damage to the internal mechanism of the gauge which would result in the gauge not operating to its specifications.Therefore, the most probable root cause of this complaint is handling damage.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

It was reported to boston scientific corporation that a nephromax balloon catheter was unpacked on an unknown date.According to the complainant, during unpacking, when they opened the outer box, the sterile packaging of the device was already opened.There was no visible damage noted on the outer box.Reportedly, this device was not used in a patient or procedure.

• 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: 6604044
• MDR Text Key: 76391664
• Report Number: 3005099803-2017-01595
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 08714729826491
• UDI-Public: (01)08714729826491(17)20200203(10)0020245409
• 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: 05/15/2017

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: 02/03/2020
• Device Model Number: M0062101420
• Device Catalogue Number: 210-142
• Device Lot Number: 0020245409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2017
• Initial Date FDA Received: 06/01/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1