MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN GATEWAY OTW 2.25MM X 15MM - HDE; CATHETER, BALLOON TYPE

Model Number	M0032072215220
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a neurovascular procedure was performed in a patient with intracranial artery stenosis in mca (middle carotid artery).During the procedure when the physician was not able to inflate the subject balloon.The physician removed the subject balloon from the patients vascular anatomy and noted that the subject balloon was ruptured.The subject balloon was replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that a neurovascular procedure was performed in a patient with intracranial artery stenosis in mca (middle carotid artery).During the procedure when the physician was not able to inflate the subject balloon.The physician removed the subject balloon from the patients vascular anatomy and noted that the subject balloon was ruptured.The subject balloon was replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿ added.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.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.The reported event is covered in the device directions 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.It was reported that the balloon was unable to inflate during the procedure, then they removed it and found it was ruptured.Additional information states that the device was prepared as per the dfu, continuous flush was maintained and the anatomy was moderately tortuous.It is possible that the device was damaged as a result of advancing through the patients anatomy, however this cannot be definitively determined.As the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause for the reported 'balloon burst/ruptured during use' and 'balloon failed to inflate', an assignable cause of undeterminable will be assigned to this complaint.

• Brand Name: GATEWAY OTW 2.25MM X 15MM - HDE
• Common Device Name: CATHETER, BALLOON TYPE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 13472304
• Report Number: 3008853977-2022-00009
• Device Sequence Number: 4826637
• Product Code: GBA
• UDI-Device Identifier: 08714729791188
• UDI-Public: 08714729791188
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup
• Report Date (Section B): 05/18/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/02/2023
• Device Model Number: M0032072215220
• Device Catalogue Number: M0032072215220
• Device Lot Number: 26119996
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GAGE - DEVICE TO INFLATE BALLOON (MEDTRONIC)
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 53 KG