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

Model Number	M00558860
Medical Device Problem Codes	Burst Container or Vessel (1074); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, 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 during an endoscopic retrograde cholangiopancreatography (ercp) with luminal dilation procedure performed on (b)(6) 2021.During the procedure, it was noted that the balloon seemed broken from the time an attempt to inflate was made.Reportedly, the balloon inflate or hold the contrast.It was reported that the procedure was completed successfully.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: device problem code a0402 captures the event of balloon leak.Block h10: investigation results visual examination of the returned complaint device revealed no visual defects and was in good condition.No damage was found on the catheter of the device.Functional analysis was performed, and the balloon was inflated normally.There were no leaks, holes or pinholes noted in the balloon.It was also noted that the balloon was able to deflate without issues.Based on the analysis performed and the information provided, the most probable root cause for the complaint event cannot be detected since the reported device complaint or problem cannot be confirmed.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a cre rx biliary dilatation balloon was used during an endoscopic retrograde cholangiopancreatography (ercp) with luminal dilation procedure performed on (b)(6) 2021.During the procedure, it was noted that the balloon seemed broken from the time an attempt to inflate was made.Reportedly, the balloon inflate or hold the contrast.It was reported that the procedure was completed successfully.There were no patient complications as a result of this event.Additional information received on march 9, 2021.It was reported that the balloon did not burst, however, it was noticed that the balloon had a small leak and would not hold pressure.The procedure was performed in the common bile duct (cbd) and duodenum, and the procedure was completed with another cre rx balloon.

• 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: 11436700
• Report Number: 3005099803-2021-00883
• Device Sequence Number: 19717660
• Product Code: FGE
• UDI-Device Identifier: 08714729965411
• UDI-Public: 08714729965411
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 04/06/2021

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: 10/24/2023
• Device Model Number: M00558860
• Device Catalogue Number: 5886
• Device Lot Number: 0026406508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1