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

Model Number	M00558870
Medical Device Problem Codes	Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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 in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the black rx tunnel detached from the catheter and was stuck inside the scope.Reportedly, the physician removed the scope from the patient and was then removed the black rx tunnel.The procedure was completed with a different device.There have been no patient complications reported as a result of this event.
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) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the black rx tunnel detached from the catheter and was stuck inside the scope.Reportedly, the physician removed the scope from the patient and was then removed the black rx tunnel.The procedure was completed with a different device.There have been no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Problem code 2907 captures the reportable issue of rx tunnel detached.Investigation results: a device was returned with a pouch; however, the pouch was not related with the complaint device and the protective sleeve covering of the balloon was returned.Visual examination of the catheter revealed no damages.The black rx tunnel was correctly attached to the catheter, and it was located on its correct place.Additionally, the black rx tunnel showed no damages nor abnormalities.Based on the analysis performed and the information provided, the most probable root cause for the complaint event is no problem detected since the 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.

• 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: 8570250
• Report Number: 3005099803-2019-02239
• Device Sequence Number: 2191283
• Product Code: FGE
• UDI-Device Identifier: 08714729965428
• UDI-Public: 08714729965428
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2019

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: 11/03/2021
• Device Model Number: M00558870
• Device Catalogue Number: 45767
• Device Lot Number: 0023027776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 06/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 107