MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NEPHROMAX; CATHETER, NEPHROSTOMY

Catalog Number M0062101170

Device Problem Hole In Material (1293)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/06/2015

Event Type  malfunction  

Event Description

Nephromax 30fx12cm sheath balloon had a hole at the end prior to use.It was discovered when the sheath was placed in the patient during the surgery.

• Brand Name: NEPHROMAX
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 5177113
• MDR Text Key: 29238546
• Report Number: 5177113
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2015,10/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/23/2018
• Device Catalogue Number: M0062101170
• Device Lot Number: 17819424
• Other Device ID Number: 08714729012641
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/23/2015
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR