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

Model Number M00558690

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 10/01/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the pylorus during a pyloric stricture dilatation procedure performed on an unknown date.During the procedure, the balloon was inflated to 3 atm without problem.However, when it was inflated to 8 atm the balloon 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 b3: approximated based on the date the manufacturer became aware of the event.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 pylorus during a pyloric stricture dilatation procedure performed on an unknown date.During the procedure, the balloon was inflated to 3 atm without problem.However, when it was inflated to 8 atm the balloon 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 b3: approximated based on the date the manufacturer became aware of the event.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 examination found no damages to the catheter of the device.The balloon was inspected, and it was found that the balloon had a longitudinal tear.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of a balloon burst cannot be confirmed.The longitudinal tear problem found in the balloon could have been interpreted by the customer as the reported event of a balloon burst.It is possible that during the procedure, the device has interacted with some sharp surface or other devices that may have caused the longitudinal tear of the balloon.It is possible that the manipulation of the device, technique used, or patient's anatomical conditions could have contributed to the physical damage on the balloon.Therefore, the most probable root cause is an adverse event related to procedure.

• 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: 18136207
• MDR Text Key: 328120169
• Report Number: 3005099803-2023-06209
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729797579
• UDI-Public: 08714729797579
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2023

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: M00558690
• Device Catalogue Number: 5869
• Device Lot Number: 0032081068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2023
• 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