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

Model Number	M00558620
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation result: a photo was submitted by the customer showing the device but no damages could be visualized.A visual examination of the returned complaint device found that the balloon and the catheter of device had no damages.Functional analysis was performed, and the balloon was inflated without a problem; however, there was a pinhole in the proximal section on the body of the balloon, which does not confirm the reported event of the balloon tearing.Based on the available information, it is possible that factors encountered during the procedure, such as interaction with the scope or any other surface causing friction during the insertion of the balloon, causing the balloon pinhole 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.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the ampula of vater during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, it was noticed that the balloon was torn and the contrast medium 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: 11568391
• Report Number: 3005099803-2021-01281
• Device Sequence Number: 11799947
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2021

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: 11/01/2023
• Device Model Number: M00558620
• Device Catalogue Number: 5862
• Device Lot Number: 0026442596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1