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 06/28/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the esophagus during an endoscopy with dilation procedure performed on (b)(6) 2022.During the procedure, the balloon was leaking at the tip near the beginning of the guidewire while being inflated towards 18mm.Although the balloon lost inflation, the procedure was completed with the original device at 18mm.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 leaked in the esophagus.Block h10: investigation results the returned cre pro wireguided dilatation balloon was analyzed and and a visual examination that the balloon and catheter of the device found 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 distal section of the balloon.Microscopic inspection found the balloon had a pinhole located approximately 15mm from the tip.With all the available information, boston scientific concludes the reported event was confirmed.It is possible that factors encountered during the procedure, such as the interaction with scope or any other surface during the procedure could create friction on the balloon and cause a pinhole.Therefore, the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used in the esophagus during an endoscopy with dilation procedure performed on june 28, 2022.During the procedure, the balloon was leaking at the tip near the beginning of the guidewire while being inflated towards 18mm.Although the balloon lost inflation, the procedure was completed with the original device at 18mm.There were no patient complications reported as a result of this event.

• 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: 15080411
• MDR Text Key: 304339119
• Report Number: 3005099803-2022-03854
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729797593
• UDI-Public: 08714729797593
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/26/2022

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: 0028765252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 08/08/2022
• Supplement Dates FDA Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2022
• 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
• Patient Sex: Male
• Patient Race: White