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

Model Number	M00558930
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2020 as no event date was reported.(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 in the papilla of vater during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.According to the complainant, when the device was removed from the patient after dilation, it was noted that the black rx tunnel came off from the catheter into the scope.Reportedly, the scope together with the device was removed from the patient, and the procedure was completed at this time.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.Block h6: problem code 2907 captures the reportable issue of rx tunnel detached.Block h10: investigation result: a visual examination of the returned complaint device confirmed that the rx tunnel of the device was detached and was not returned with the device.It was also noticed that the nylon sleeve was present and was adhered to the shaft.This failure is likely due to factors or conditions related to handling of the device, the technique used by the physician and normal procedural difficulties encountered during the procedure.Therefore, the most probable root cause is adverse event related to procedure.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 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 in the papilla of vater during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.According to the complainant, when the device was removed from the patient after dilation, it was noted that the black rx tunnel came off from the catheter into the scope.Reportedly, the scope together with the device was removed from the patient, and the procedure was completed at this time.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 9923124
• Report Number: 3005099803-2020-01376
• Device Sequence Number: 11342872
• Product Code: FGE
• UDI-Device Identifier: 08714729965480
• UDI-Public: 08714729965480
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K172520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2020

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: 07/28/2021
• Device Model Number: M00558930
• Device Catalogue Number: 45767
• Device Lot Number: 0022574595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1