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

Model Number	M00558470
Medical Device Problem Codes	Material Puncture/Hole (1504); Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation result: a visual examination of the complaint device revealed the device did not have any visual defects.The inner radio opaque (ro) markers inside the balloon were inspected for any sharp edge but none of them showed abnormalities.Functional analysis was performed, and the balloon was inflated; however, a pinhole was found on the body of the balloon.This failure is likely due to an interaction between the user and device, or sample, that caused or contributed to the error.It is likely that the failure may be related to the balloon being pre-tested and the handling of the device during the procedure.Therefore, the most probable root cause is unintended use error caused or contributed to event.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 directions for use (dfu)/product label as the device was pre-inflated.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was used during a biliary dilation procedure performed on (b)(6) 2018.According to the complainant, during preparation, the balloon was pre-inflated and it was noticed that the balloon leaked.The procedure was not completed as another of the same device was not available.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Investigation results revealed that the balloon found a pinhole.

• 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: 8371785
• Report Number: 3005099803-2019-00735
• Device Sequence Number: 1734335
• Product Code: FDT
• UDI-Device Identifier: 08714729339403
• UDI-Public: 08714729339403
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K110833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2019

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: 02/18/2021
• Device Model Number: M00558470
• Device Catalogue Number: 5847
• Device Lot Number: 0021893971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1