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

Model Number	M00558930
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2019
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 in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, while physician was performing sphincteroplasty, a small hole opened in the side of the balloon and water started to stream out causing the balloon to deflate.The procedure was completed with a different device.There have been no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: problem code 1504 captures the reportable event of balloon pinhole.Block h10: investigation results visual examination of the returned complaint device revealed the balloon did not show visual defects and looked normal.No damage found on the catheter of the device.Functional analysis was performed, and the balloon was inflated without a problem; however, balloon would not hold pressure due to a pinhole found over the ro marker.This failure is likely due to factors or conditions related to the procedure that could have affected its performance and its intended purpose such as; the manner the device was handled, and/or the interaction with the scope 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.
Event or Problem Description
It was reported to boston scientific corporation that a cre rx biliary dilatation balloon was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, while physician was performing sphincteroplasty, a small hole opened in the side of the balloon and water started to stream out causing the balloon to deflate.The procedure was completed with a different device.There have been no patient complications reported as a result of this event.The patient 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: 8737051
• Report Number: 3005099803-2019-03238
• Device Sequence Number: 13929441
• Product Code: FGE
• UDI-Device Identifier: 08714729965480
• UDI-Public: 08714729965480
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2019

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: 01/04/2022
• Device Model Number: M00558930
• Device Catalogue Number: 45767
• Device Lot Number: 0023290456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 08/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1