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

Model Number M00558670

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

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

Event Date 05/17/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a040609 captures the reportable event of balloon material twisted/bent.

Event Description

Note: this report pertains to two cre pro wireguided dilatation balloon that were used in the same patient and procedure.It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used an unknown procedure performed on (b)(6) 2023.During the procedure, while the pediatric consultant and registrar performing gastroscopy, they were unable to feed through the dilatation catheter due to a faulty tip.The procedure was completed using an alternate device.No patient complications have been reported as a result of the 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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17078862
• MDR Text Key: 316866178
• Report Number: 3005099803-2023-02938
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729797555
• UDI-Public: 08714729797555
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K112994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00558670
• Device Catalogue Number: 5867
• Device Lot Number: 0029170186
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2022
• 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
• Patient Age: 10 MO
• Patient Sex: Male