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

Model Number	M0062101420
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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¿
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6604044
• Report Number: 3005099803-2017-01595
• Device Sequence Number: 1010458
• Product Code: LJE
• UDI-Device Identifier: 08714729826491
• UDI-Public: (01)08714729826491(17)20200203(10)0020245409
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K952968
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 06/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1