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

Model Number	M00558460
Medical Device Problem Codes	Inflation Problem (1310); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual examination of the returned complaint device found that the balloon and the catheter of the device had no damages.Functional analysis was performed, and the balloon was inflated without a problem; however, there was a pinhole in the distal section on the body of the balloon, which does confirm the reported event of the balloon could not be inflated.Based on the available information, it is possible that factors encountered during the procedure, such as interaction with the scope or any other surface causing friction during the insertion of the balloon, causing the balloon pinhole 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 used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used in the ampulla of vater during a cre balloon sphincteroplasty procedure performed on (b)(6) 2021.During the procedure, the balloon was attempted to be inflated; however, it was noticed that the balloon could not be inflated.The procedure was completed with another cre wireguided dilatation balloon.There were no patient complications reported as a result of this event.Investigation results revealed that this balloon has a pinhole; therefore, this is now an mdr reportable event.

• Brand Name: CRE WIREGUIDED
• Common Device Name: DILATOR, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11855909
• Report Number: 3005099803-2021-02254
• Device Sequence Number: 19088032
• Product Code: FDT
• UDI-Device Identifier: 08714729339397
• UDI-Public: 08714729339397
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K110833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2022
• Device Model Number: M00558460
• Device Catalogue Number: 5846
• Device Lot Number: 0023629484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 79