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

Model Number	M00558940
Medical Device Problem Codes	Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre rx biliary dilatation balloon was used during a procedure performed on (b)(6) 2023.It was reported that there was a kink at the distal part of the balloon sheath.The sheath must be clipped in the opposite direction to inflate the balloon.No patient complications have been reported as a result of this event.No further information has been obtained despite good-faith efforts.
Additional Manufacturer Narrative
Block h6: imdrf device code a040609 captures the reportable event of tip bent.
Additional Manufacturer Narrative
Block h6: imdrf device code a040609 captures the reportable event of tip bent.Block h10: investigation results: the returned cre rx biliary dilatation balloon was analyzed, and a visual evaluation found that the tip of the balloon was in good condition and the catheter was kinked about 71 mm from the bifurcation.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of kink at the distal part of the balloon sheath was not confirmed.It is possible that during the procedure the device faced some resistance that could have caused the catheter to bend.Perhaps the manipulation, the technique used, or the anatomical conditions of the patient could also have contributed to this event.A kink in the catheter may require the device to be replaced during the procedure and cause a clinically insignificant delay of the procedure.Therefore, the most probable root cause is no problem detected.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a cre rx biliary dilatation balloon was used during a procedure performed on (b)(6) 2023.It was reported that there was a kink at the distal part of the balloon sheath.The sheath must be clipped in the opposite direction to inflate the balloon.No patient complications have been reported as a result of this event.No further information has been obtained despite good-faith efforts.

• Brand Name: CRE RX
• Common Device Name: 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: 17491139
• Report Number: 3005099803-2023-04236
• Device Sequence Number: 15297940
• Product Code: FGE
• UDI-Device Identifier: 08714729965497
• UDI-Public: 08714729965497
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K172520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2026
• Device Model Number: M00558940
• Device Catalogue Number: 5894
• Device Lot Number: 0031396708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown