MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX URETERAL STENT; CATHETER, NEPHROSTOMY, GENERAL AND PLASTIC SURGERY

Model Number M0061453810

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2019

Event Type  malfunction  

Event Description

Boston scientific, percuflex ureteral stent.Was kinked in the sterile packaging when the device was opened.The device was unable to be utilized.Fda safety report id # (b)(4).

• Brand Name: PERCUFLEX URETERAL STENT
• Type of Device: CATHETER, NEPHROSTOMY, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; marlborough MA 01752
• MDR Report Key: 9489351
• MDR Text Key: 171984767
• Report Number: MW5091709
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/13/2019

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: 05/06/2022
• Device Model Number: M0061453810
• Device Catalogue Number: M0061453810
• Device Lot Number: 23755669
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 93 YR