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

Model Number M00558850

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 12/07/2023

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 gi wireguided dilatation balloon was used in the large intestine during a gastroduodenectomy procedure performed on (b)(6) 2023.During the procedure, the balloon is inflated but immediately shrinks.It is highly possible that the balloon burst.The customer stated that no pieces of the balloon detached inside the patient.The procedure was not completed and was canceled because there was no substitute product.The customer is planning to reschedule the procedure within the month.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 gi dilatation balloon was analyzed, and a visual examination found that the balloon and catheter of the device had no damages.Functional analysis was performed, and the balloon was inflated without a problem.However, the balloon would not hold pressure due to a pinhole in the balloon (distal section), located approximately 12 mm from the tip.Microscopic inspection found a pinhole located approximately at 12 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 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.

Event Description

It was reported to boston scientific corporation that a cre pro gi wireguided dilatation balloon was used in the large intestine during a gastroduodenectomy procedure performed on (b)(6) 2023.During the procedure, the balloon is inflated but immediately shrinks.It is highly possible that the balloon burst.The customer stated that no pieces of the balloon detached inside the patient.The procedure was not completed and was canceled because there was no substitute product.The customer is planning to reschedule the procedure within the month.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: 18411071
• MDR Text Key: 331531787
• Report Number: 3005099803-2023-06925
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00558850
• Device Catalogue Number: 5885
• Device Lot Number: 0031997993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2023
• 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