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

Model Number	M00558920
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a cre rx biliary dilatation balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) with cholangioscopy procedure performed on (b)(6) 2021.It was reported that the balloon catheter was difficult to remove from the working channel by the physician and the tech.After pulling the device from the scope, it was found that the black rx tunnel and the distal part of the balloon detached and were stuck in the scope.The balloon was accidentally pushed into the cbd of the patient and was retrieved with an extractor balloon and rat tooth forceps.The procedure was completed at this time.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
• MDR Report Key: 11567846
• Report Number: 3005099803-2021-01276
• Device Sequence Number: 4150799
• Product Code: FGE
• UDI-Device Identifier: 08714729965473
• UDI-Public: 08714729965473
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2021

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 Expiration Date: 12/14/2023
• Device Model Number: M00558920
• Device Catalogue Number: 5892
• Device Lot Number: 0026625811
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention