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

Model Number	M00558670
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the esophagus during a dilation procedure performed on (b)(6) 2021.During the procedure, the balloon was able to be inflated to 8mm and 9mm without issue; however, upon attempting to reach the inflation to 10mm, the balloon burst.There were no patient complications reported as a result of the event.
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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the esophagus during a dilation procedure performed on (b)(6) 2021.During the procedure, the balloon was able to be inflated to 8mm and 9mm without issue; however, upon attempting to reach the inflation to 10mm, the balloon burst.There were no patient complications reported as a result of the event.Additional information received on november 24, 2021 it was reported that the procedure was already completed when the balloon burst and the scope was removed.
Additional Manufacturer Narrative
Block h2: additional infomation: block b5 (describe event or problem).Block h6: device code a0402 captures the reportable issue of balloon burst.Block h10: the device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the esophagus during a dilation procedure performed on (b)(6) 2021.During the procedure, the balloon was able to be inflated to 8mm and 9mm without issue; however, upon attempting to reach the inflation to 10mm, the balloon burst.There were no patient complications reported as a result of the event.***additional information received on (b)(6), 2021*** it was reported that the procedure was already completed when the balloon burst and the scope was removed.
Additional Manufacturer Narrative
Block h6: device code a0402 captures the reportable issue of balloon burst.Block h10: the returned cre wireguided dase balloon was analyzed, and a visual evaluation noted that the balloon was torn circumferentially.A microscopic evaluation noted that the circumferential tear was 60 mm from the tip.No other problems with the device were noted.The circumferential tear problem found could have been interpreted by the customer as the reported event of balloon burst.The torn problem found in the balloon is likely to have occurred due to factors encountered during the procedure, device interaction with a scope.These factors and interactions could influence the damage found in the balloon.However, it is possible that interaction with any surface during the procedure could create friction on the balloon, causing the problem of circumferential tear during the procedure.For this reason, the event is classified as "adverse event related to procedure" because the adverse event occurred during the procedure and the device had no influence on the event.

• Brand Name: CRE PRO
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12885330
• Report Number: 3005099803-2021-05988
• Device Sequence Number: 4024908
• Product Code: FGE
• UDI-Device Identifier: 08714729797555
• UDI-Public: 08714729797555
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/23/2021

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: 02/23/2024
• Device Model Number: M00558670
• Device Catalogue Number: 5867
• Device Lot Number: 0027031944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 11/24/2021; 12/07/2021
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 12/07/2021; 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown