MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN GATEWAY OTW 2.0MM X 15MM - HDE; CATHETER, BALLOON TYPE

Model Number	M0032072215200
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.Visual inspection stated that damage was noted to the gateway catheter shaft at approximately 41cm and 82cm from the proximal end of the device.No damage visible inside the inflation port.Functional test reported that an attempt was made to inflate the balloon with an encore 26 inflation device; however, the balloon was noted to be leaking at the proximal end.The reported event is covered in the device directions for use direction for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.As per the available information, the device was confirmed to be in good condition during preparation/prior to use on the patient, continuous flush was set up and maintained throughout the clinical procedure and the patients anatomy was described as 'quite tortuous'.It was also reported that the balloon was successfully inflated during preparation.The device was returned and the balloon was noted to be leaking during analysis.It is probable that the balloon was damaged during navigation through the patients anatomy, causing the reported event.An assignable cause of procedural factors will be assigned to the as reported code balloon failed to inflated, and as analyzed codes the balloon leaked during use and to the balloon catheter damaged as the issue is associated with a product that meets boston scientific design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
Analysis of the returned device found that the subject balloon catheter was leaking from the proximal end.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: GATEWAY OTW 2.0MM X 15MM - HDE
• Common Device Name: CATHETER, BALLOON TYPE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• MDR Report Key: 12530651
• Report Number: 3008853977-2021-00035
• Device Sequence Number: 4460767
• Product Code: GBA
• UDI-Device Identifier: 08714729791416
• UDI-Public: 08714729791416
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: H050001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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: 01/02/2023
• Device Model Number: M0032072215200
• Device Catalogue Number: M0032072215200
• Device Lot Number: 24979114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 57