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

Model Number	M00558870
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	01/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation result: a visual examination of the returned complaint device confirmed that the rx tunnel was detached.Only the rx tunnel and the shipping mandrel of the device were returned; the catheter and the balloon were not returned with the device.It was reported that the device was use in the scope with 3.2 mm working channel.The dfu states that the cre rx biliary balloon dilatation catheter is designed to pass through an endoscope with a minimum 3.7 mm working channel; the balloon was inserted in a smaller scope than indicated in the dfu which could cause the alleged issue.Based on the condition and evaluation of the returned device, the most probable root cause is failure to follow instructions since the problem was traced to the user not following the manufacturer's instructions.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.
Event or Problem Description
Note: this report pertains to one of two cre rx biliary dilatation balloons used in the same patient and procedure.It was reported to boston scientific corporation that two cre rx biliary dilatation balloons were used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the black rx tunnel of the device was detached inside the patient.Reportedly, it was noted that the working channel of the scope was too tight during advancement of the device down the scope.The detached part was retrieved using a rat tooth forceps.The same issue occurred with the second cre rx biliary dilatation balloon and they completed the procedure 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: 8316861
• Report Number: 3005099803-2019-00443
• Device Sequence Number: 13719202
• Product Code: FGE
• UDI-Device Identifier: 08714729965428
• UDI-Public: 08714729965428
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 02/07/2019

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: 10/27/2020
• Device Model Number: M00558870
• Device Catalogue Number: 45767
• Device Lot Number: 0021434017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 02/07/2019
• 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