MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN GATEWAY OTW 1.5MM X 15MM - HDE; CATHETER, BALLOON TYPE

Model Number	M0032072215150
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that the subject balloon could not inflate during an intracranial artery stenosis procedure.Upon removal, the physician noted the balloon (subject device) has ruptured.The patient's anatomy was moderately tortuous.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that the subject balloon could not inflate during an intracranial artery stenosis procedure.Upon removal, the physician noted the balloon (subject device) has ruptured.The patient's anatomy was moderately tortuous.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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 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.The reported event could not be confirmed and it cannot be confirmed that the device met specification, as the device was not returned.It was reported that, the balloon was unable to inflate during the procedure.They removed it and found it was ruptured.Additional information stated that there were no anomalies noted to the device prior to use, the device prepared as per the dfu, continuous flush was maintained and the anatomy was moderately tortuous.As the device was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause for the reported event of the device burst/ruptured during use and difficult to inflate, an assignable cause of undeterminable will be assigned to this complaint.H3 other text : device not returned for evaluation.

• Brand Name: GATEWAY OTW 1.5MM 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: 13087159
• Report Number: 3008853977-2021-00047
• Device Sequence Number: 5333977
• Product Code: GBA
• UDI-Device Identifier: 08714729791300
• UDI-Public: 08714729791300
• 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): 04/26/2022

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: 10/02/2023
• Device Model Number: M0032072215150
• Device Catalogue Number: M0032072215150
• Device Lot Number: 26119994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 12/27/2021
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2020
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER); GAGE ( METRONIC)
• Patient Age: 72 YR
• Patient Sex: Female