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

Model Number	M00558620
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual examination of the returned complaint device found the balloon and the catheter did not have any visual defects and were in a good condition.Functional evaluation was performed and the balloon was inflated without problem; however, the balloon would not hold pressure due to two pinholes located at the proximal and middle section of the body of the balloon, thereby confirming the reported event of balloon leak.It is possible that the interaction between the balloon with scope or any other surface during the procedure could have created friction on the balloon, causing the found problem of balloon pinhole.Therefore, the most probable root cause is adverse event related to procedure because the adverse event occurred during the procedure and the device had no influence on event.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) procedure performed on (b)(6) 2021.During the procedure, it was noticed that the balloon was leaking when inflated.The procedure was completed with another cre pro wireguided dilatation balloon.This event has been deemed a reportable event based on the investigation finding of balloon pinholes.There were 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 PRO
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12264044
• Report Number: 3005099803-2021-03916
• Device Sequence Number: 4066800
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/02/2021

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: 06/07/2023
• Device Model Number: M00558620
• Device Catalogue Number: 5862
• Device Lot Number: 0025678894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 08/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR