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

Model Number	M00558860
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Note: this report pertains to one of two cre rx dilatation balloons used in the same patient and procedure.It was reported to boston scientific corporation that a cre rx dilatation balloon was attempted to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the rx tunnel (black segment or sheath) of the device detached inside the patient and stent deployment could not be performed.A photo of the device was provided by the customer and showed that the rx tunnel of the device was detached.The detached rx tunnel was able to be removed from the patient using graspers.The same problem occurred with the second cre rx dilatation balloon.The procedure was completed with a third cre rx dilatation balloon and the stent was able to be placed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: this event was reported by the sales representative.The healthcare facility is: (b)(6).Block h6: imdrf device code a0501 captures the reportable event of balloon rx tunnel detachment.Imdrf impact code f2301 is being used to capture the reportable event of additional device required.
Additional Manufacturer Narrative
Block e1: this event was reported by the sales representative.The healthcare facility is: (b)(6).Block h6: imdrf device code a0501 captures the reportable event of balloon rx tunnel detachment.Imdrf impact code f2301 is being used to capture the reportable event of additional device required.Block h10: investigation results: the returned cre rx dilatation balloon was analyzed, and a visual found that the rx tunnel (black sheath) was detached.Also, the catheter was found kinked, specifically in the portion of the missing black sheath.Media inspection found one of the photos showed the black sheath attached to the device and the second photo showed the black sheath after being detached from the device.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of rx tunnel detachment was confirmed.The results of the analysis performed on the returned device found that the device returned with the rx tunnel (black sheath) detached.Also, the catheter was found kinked specifically in the portion of the missing black sheath.It is possible that the rx tunnel detachment occurred due to procedural factors such as excess of force, pressure or anatomical conditions.Also, it is possible that interaction with a sharp surface during or previous to the procedure could have caused the rx tunnel to detach.Therefore, the most probable root cause is an adverse event related to procedure.
Event or Problem Description
Note: this report pertains to one of two cre rx dilatation balloons used in the same patient and procedure.It was reported to boston scientific corporation that a cre rx dilatation balloon was attempted to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the rx tunnel (black segment or sheath) of the device detached inside the patient and stent deployment could not be performed.A photo of the device was provided by the customer and showed that the rx tunnel of the device was detached.The detached rx tunnel was able to be removed from the patient using graspers.The same problem occurred with the second cre rx dilatation balloon.The procedure was completed with a third cre rx dilatation balloon and the stent was able to be placed.There were no patient complications reported as a result of this event.

• 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: 19076147
• Report Number: 3005099803-2024-01568
• Device Sequence Number: 6825703
• Product Code: FGE
• UDI-Device Identifier: 08714729965411
• UDI-Public: 08714729965411
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00558860
• Device Catalogue Number: 5886
• Device Lot Number: 0033295544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown