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	07/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation result a visual examination of the returned complaint device found that the balloon did not have any visual defects and was in a good condition.No damage was found on the catheter of the device.Functional analysis was performed, and the balloon was inflated without a problem; however, there was a pinhole over the shoulder of the body of the balloon.Based on the available information, the failure reported may be related to some factors, such as interaction with the scope that could have caused the physician to use force during insertion of the balloon in the working channel that could have resulted in the reported failure.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 not used per the directions for use (dfu)/product label as the balloon was pre-inflated.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon was attempted to be inflated; however, it was noticed that the balloon was leaking.It was noted that the balloon had been pre-tested prior to use in the patient.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 this 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: 10977452
• Report Number: 3005099803-2020-05911
• Device Sequence Number: 3299559
• Product Code: FGE
• UDI-Device Identifier: 08714729797500
• UDI-Public: 08714729797500
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 12/09/2020

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: 09/16/2022
• Device Model Number: M00558620
• Device Catalogue Number: 5862
• Device Lot Number: 0024610319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1