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

Model Number M00558440

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504); Use of Device Problem (1670)

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

Event Date 02/24/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the esophagus during esophageal procedure performed on (b)(6)2022.During preparation, it was noticed that the balloon was leaking liquid after injecting the liquid.The procedure was completed with another cre wireguided dilatation balloon.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was pre-inflated outside of the patient.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of balloon pinhole.

Manufacturer Narrative

(b)(4).Investigation results: a visual examination of the returned complaint device found that the balloon and the catheter of the device had no damages.Microscopic inspection was done and found the balloon had a pinhole, which confirms the reported event.The guidewire of the device was noted to be bent.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 on the body of the balloon.It is possible that interaction with any surface during the procedure could create friction on the balloon, causing the balloon leak during the procedure.Additionally the guidewire bent likely occurred due to the manipulation of the catheter during the procedure.Therefore, the most probable root cause is adverse event related to procedure.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 not used per the instructions for use (ifu)/product label as the balloon was pre-inflated.

Event Description

It was reported to boston scientific corporation that a cre balloons - wireguided was used in the esophagus during esophageal procedure performed on (b)(6) 2022.During the procedure, it was noticed that the balloon was leaking liquid after injecting the liquid.The procedure was completed with another cre balloons - wireguided device.There were no patient complications reported as a result of this event investigation results revealed that the balloon had a pinhole and the device was used in the esophagus; therefore, this is now an mdr reportable event per (b)(4), dilatation balloons pinholes quality plan.

Manufacturer Narrative

Block h2: correction: block h6 (device codes) and block h10 (additional mfr narrative) block h6: device code a041001 captures the reportable investigation result of balloon pinhole.Block h10: investigation results a visual examination of the returned complaint device found that the balloon and the catheter of the device had no damages.Microscopic inspection was done and found the balloon had a pinhole, which confirms the reported event.The guidewire of the device was noted to be bent.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 on the body of the balloon.Based on the evidence, it was reported that the physician pre-inflated the balloon before inserting in the working channel, this can provoke the pinhole found in the balloon, this problem can occur due to misuse of the ifu.Taking all available information into consideration, the most probable root cause is failure to follow instructions, since it was determined that the problems with the device can be traced to the user not following the manufacturer instructions.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 not used per the instructions for use (ifu)/product label as the balloon was pre-inflated.

• Brand Name: CRE WIREGUIDED
• 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: 14107217
• MDR Text Key: 289257082
• Report Number: 3005099803-2022-02071
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 08714729339373
• UDI-Public: 08714729339373
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K110833
• 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: 05/17/2022

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 Expiration Date: 01/02/2024
• Device Model Number: M00558440
• Device Catalogue Number: 5844
• Device Lot Number: 0026731341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 04/21/2022
• Supplement Dates FDA Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2021
• 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 Age: 83 YR
• Patient Sex: Male
• Patient Weight: 36 KG