MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE FIXED WIRE; DILATOR, ESOPHAGEAL

Model Number M00558380

Device Problems Burst Container or Vessel (1074); Material Deformation (2976)

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

Event Date 06/27/2022

Event Type  malfunction  

Event Description

A cre fixed wire dilatation balloon was returned to boston scientific corporation on (b)(6) 2022 without any report of performance issues or adverse patient effects.The returned device was analyzed and was noted to have ruptured.

Manufacturer Narrative

Exact date unknown, device received on (b)(6) 2022 (b)(4).Investigation results: the returned cre fixed wire dilatation balloon was analyzed and a visual and microscopic examination found that the balloon was ruptured and the catheter was bent at 69 cm from the connector.With all the available information, boston scientific concludes the rupture found in the balloon is likely to have occurred due to factors encountered during the procedure; excess pressure, interaction with other devices, or anatomical affairs.It is possible that factors encountered during the procedure, such as the interaction with any surface, could create friction on the balloon and cause it to rupture.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.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 FIXED WIRE
• 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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15130850
• MDR Text Key: 304339650
• Report Number: 3005099803-2022-04098
• Device Sequence Number: 1
• Product Code: KNQ
• UDI-Device Identifier: 08714729202011
• UDI-Public: 08714729202011
• Combination Product (y/n): N
• PMA/PMN Number: K971320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/03/2023
• Device Model Number: M00558380
• Device Catalogue Number: 5838
• Device Lot Number: 0028317836
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1