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

Model Number	M00558930
Medical Device Problem Codes	Material Puncture/Hole (1504); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Should the device become available for analysis and there is any further relevant information, 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 during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.It was reported that during preparation, the balloon was tested prior to use in a procedure, and it was noticed that the balloon was leaking due to a small hole.The procedure was completed with another cre rx biliary dilatation balloon.Note: the instructions for use (ifu) indicate that the balloon should not be pre-inflated.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation, that a cre rx biliary dilatation balloon was used, during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure.Performed on (b)(6) 2021.It was reported, that during preparation.The balloon was tested, prior to use in a procedure.And it was noticed, that the balloon was leaking, due to a small hole.The procedure was completed with another cre rx biliary dilatation balloon.Note: the instructions for use (ifu), indicate that the balloon should not be pre-inflated.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a041001, captures the reportable event of balloon pinhole.Block h10: investigation result: a visual examination of the returned complaint device, found the balloon did not show visual defects.The catheter of the device was carefully inspected and no damages were found.Functional analysis was performed, and the balloon was inflated without a problem.However, the balloon would not hold pressure, due to a pinhole located at the proximal section of the body of the balloon.Thereby confirming, the reported event.This failure is likely, due to factors encountered during the procedure, such as the technique used by the physician, and/or the interaction between the balloon and the scope, during the procedure.Resulting to the found, failure 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.A labeling review was performed.And from the information available, this device was not used, per the instructions for use (ifu)/product label.As the balloon was pre-inflated.

• 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: 11509398
• Report Number: 3005099803-2021-01063
• Device Sequence Number: 2777088
• Product Code: FGE
• UDI-Device Identifier: 08714729965480
• UDI-Public: 08714729965480
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K172520
• 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,Followup
• Report Date (Section B): 04/27/2021

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: 07/15/2022
• Device Model Number: M00558930
• Device Catalogue Number: 5893
• Device Lot Number: 0024275312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1