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

Model Number	M00558620
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation result a visual examination of the returned complaint device found that the balloon and catheter did not have any visual defects.Functional analysis was performed, and the balloon was inflated without a problem; however, the balloon would not hold pressure due to several pinholes in the balloon.The pinhole confirms the reported event of the balloon leaking.This failure is likely due to factors or conditions related to the procedure during the use of the device, such as the interaction with the scope or any other surface in the papilla anatomy, that created friction that could have caused the balloon pinhole.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 pro wireguided dilatation balloon was used in the papilla during an endoscopic papillary balloon dilation (epbd) and endoscopic balloon sphincteroplasty procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon was injected with contrast; however, it was noticed that the balloon was leaking.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.Investigation results revealed that the balloon had a pinhole; therefore, this is now an mdr reportable event.

• Brand Name: CRE PRO
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10992489
• Report Number: 3005099803-2020-05936
• Device Sequence Number: 14377381
• Product Code: FGE
• UDI-Device Identifier: 08714729797500
• UDI-Public: 08714729797500
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K112994
• 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
• Report Date (Section B): 12/11/2020

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: 03/30/2023
• Device Model Number: M00558620
• Device Catalogue Number: 5862
• Device Lot Number: 0025482003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR