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

Model Number M00558690

Device Problems Difficult to Advance (2920); Material Twisted/Bent (2981)

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

Event Date 02/09/2024

Event Type  malfunction  

Manufacturer Narrative

H6: imdrf device code a040609 captures the reportable event of balloon tip bent.

Event Description

It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the colon during a colonoscopy procedure performed on (b)(6) 2024.During insertion, when the physician went to insert the balloon, it was difficult to advance and immediately got stuck.The physician's staff reported that the tip was bent and would not advance.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.

• 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: 18849287
• MDR Text Key: 337033959
• Report Number: 3005099803-2024-00842
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729797579
• UDI-Public: 08714729797579
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00558690
• Device Catalogue Number: 5869
• Device Lot Number: 0031672149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2023
• 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