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

Model Number M00558680

Device Problems Burst Container or Vessel (1074); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.

Event Description

It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the bile duct papilla was initially inflated with a 10 mm balloon without any problem, and a quarry was performed with an extractor balloon.Subsequently, a 12 mm balloon was used for further inflation, but the balloon burst in the middle of the process, preventing further inflation.The physician reported that the remaining stones when quarrying was performed may have interfered and might have caused the balloon to burst.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h10: investigation results the returned cre pro wireguided dilatation balloon was analyzed, and a visual inspection found no damages to the device.Functional and microscopic inspection found that the balloon had a pinhole located approximately at 70 mm from the tip of the device.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon burst was not confirmed.The pinhole problem found could have been interpreted by the customer as the reported event of a balloon burst.The pinhole found is likely to have occurred due to procedural factors such as excess of pressure, interaction with other devices, or anatomical conditions.Also, it is possible that interaction with a sharp surface during or previous to the procedure could have caused the problem found on the distal section of the balloon.Therefore, the most probable root cause is an adverse event related to procedure.Block h11: additional information: block b5 (describe event or problem).

Event Description

It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the bile duct papilla was initially inflated with a 10 mm balloon without any problem, and a quarry was performed with an extractor balloon.Subsequently, a 12 mm balloon was used for further inflation, but the balloon burst in the middle of the process, preventing further inflation.The physician reported that the remaining stones when quarrying was performed may have interfered and might have caused the balloon to burst.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.Additional information received on april 2, 2024.The balloon burst at 11 mm.The customer stated that no pieces of the balloon detached inside the patient.

• Brand Name: CRE PRO
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19008741
• MDR Text Key: 338983805
• Report Number: 3005099803-2024-01239
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729797562
• UDI-Public: 08714729797562
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

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
• Device Operator: Health Professional
• Device Model Number: M00558680
• Device Catalogue Number: 5868
• Device Lot Number: 0032838232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: 04/02/2024
• Supplement Dates FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1