MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO GI; DILATOR, ESOPHAGEAL

Model Number M00558840

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 07/01/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a cre pro wire guided dilatation balloon was used in the colon during a gastrointestinal dilatation procedure on an unknown date.During the procedure, it was noted that the balloon ruptured at 7 atm when it was attempted to perform dilatation using an 18mm size.The procedure was completed with another a cre pro wire guided 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.

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 and microscopic examination of the device found that the balloon was torn longitudinally.No damage was found on the catheter of the device.With all the available information, boston scientific concludes the reported event of balloon burst was not confirmed.The balloon was found to be torn longitudinally, likely due to factors encountered during the procedure, such as excess pressure, interaction with other devices, or anatomical affairs.These factors and interactions could influence the damage found in the balloon and caused the balloon to be torn longitudinally, which was perceived as a burst during the procedure.Therefore, the most probable root cause is adverse event related to procedure.

Event Description

It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the colon during a gastrointestinal dilatation procedure on an unknown date.During the procedure, it was noted that the balloon ruptured at 7atm when it was attempted to perform dilatation using an 18mm size.The procedure was completed with another a cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.

• Brand Name: CRE PRO GI
• Type of Device: DILATOR, ESOPHAGEAL
• 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: 17568320
• MDR Text Key: 322023434
• Report Number: 3005099803-2023-04293
• Device Sequence Number: 1
• Product Code: KNQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K971320
• 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: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00558840
• Device Catalogue Number: 5884
• Device Lot Number: 0031193962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2023
• 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