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

Model Number M00558710

Device Problem Leak/Splash (1354)

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

Event Date 12/15/2022

Event Type  malfunction  

Manufacturer Narrative

Device code a0504 captures the reportable event of balloon leak in the esophagus.

Event Description

It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the esophagus during gastro dilatation procedure performed on (b)(6) 2022.During the procedure, the physician noted a leak on the distal part of the balloon.The procedure was completed with another cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the esophagus during gastro dilatation procedure performed on (b)(6) 2022.During the procedure, the physician noted a leak on the distal part of the balloon.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: device code a0504 captures the reportable event of balloon leak in the esophagus.Block h10: investigation results: the returned cre pro wireguided dilatation balloon was analyzed and a visual examination found no damages to the catheter or balloon of the device.Microscopic evaluation of the device revealed that the balloon had a pinhole located approximately 15 mm from the tip of the device.There was no other damage observed on the device.The device was connected to an alliance inflation system for functional testing.Functional testing found that the balloon could be inflated but was unable to hold its pressure due to the pinhole located in the distal section of the balloon.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon leak was confirmed as a leak was found and the device cannot hold stable pressure.It is possible that factors encountered during the procedure, such as the excess pressure, interaction with other devices, or anatomical affairs could cause physical damage to the balloon.It is possible that interaction with any surface during the procedure could create friction on the balloon, causing a leak during the procedure.Therefore, the most probable root cause of the balloon failing to deflate is adverse event related to procedure.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.

Event Description

It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the esophagus during gastro dilatation procedure performed on (b)(6) 2022.During the procedure, the physician noted a leak on the distal part of the balloon.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

Correction: correction: block g1 (mfr site address 2) and block h10 (investigation results).Device code a0504 captures the reportable event of balloon leak in the esophagus.Investigation results the returned cre pro wireguided dilatation balloon was analyzed and a visual examination found no damages to the catheter or balloon of the device.Microscopic evaluation of the device revealed that the balloon had a pinhole located approximately 15 mm from the tip of the device.There was no other damage observed on the device.The device was connected to an alliance inflation system for functional testing.Functional testing found that the balloon could be inflated but was unable to hold its pressure due to the pinhole located in the distal section of the balloon.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon leak was confirmed as a pinhole was found and the device could not hold stable pressure during functional testing.It is possible that factors encountered during the procedure, such as the excess pressure, interaction with other devices, or anatomical affairs could cause physical damage to the balloon.It is possible that interaction with any surface during the procedure could create friction on the balloon, causing a leak during the procedure.Therefore, the most probable root cause is adverse event related to procedure.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.

• 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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16126503
• MDR Text Key: 308562865
• Report Number: 3005099803-2022-07956
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729797593
• UDI-Public: 08714729797593
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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,Followup
• Report Date: 02/21/2023

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: M00558710
• Device Catalogue Number: 5871
• Device Lot Number: 0028796340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 01/09/2023
• Supplement Dates Manufacturer Received: 01/26/2023; 01/26/2023
• Supplement Dates FDA Received: 02/21/2023; 02/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2022
• 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