MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO; CATHETER, BILIARY, DIAGNOSTIC

Model Number M00558710

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2023

Event Type  malfunction  

Event Description

Note: this report pertains to one of two cre pro wireguided dilatation balloons used during the same procedure.It was reported to boston scientific corporation that two cre pro wireguided dilatation balloon were used during a dilation procedure performed on an unknown date.During the procedure, both cre balloons did not maintain pressure and water leaked out.The procedure was completed.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0504 captures the reportable event of balloon leak in an unknown anatomy location.

• Brand Name: CRE PRO
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17491140
• MDR Text Key: 321071708
• Report Number: 3005099803-2023-04206
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729797593
• UDI-Public: 08714729797593
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/09/2023

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 Model Number: M00558710
• Device Catalogue Number: 5871
• Device Lot Number: 0031591115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2023
• 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