MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY OTW OUS 2.00MM X 15MM; CATHETER, BALLOON TYPE

Catalog Number M0032072415200

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that the balloon leaked air during the procedure.There were no reported clinical consequences to the patient.

Manufacturer Narrative

Manufacturing date ¿ added.Device evaluated by mfg ¿updated.Summary attached - updated.Expiration date - added.Product available to stryker ¿ updated.Returned to manufacturer on ¿ updated.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was returned wrapped around itself.The guidewire used with the catheter was not returned.Visual inspection revealed crystallized substances in the inflation lumen and also in the balloon.The balloon was found to be punctured on its proximal side and unfolded.There were no issues observed with the coating and no other anomalies were observed.During functional testing, the 0.014" demonstration guidewire was introduced and advanced through the catheter proximal end without any difficulties.During inflation testing, the inflation device filled with water and the balloon could not be inflated and was leaking on its proximal balloon section.Information available indicated that the device was confirmed to be in good condition post unpacking, inspection and prior to use, the device was prepared as per the dfu, and the physician used contrast medium for purging of the balloon.However, based on the information currently available a definitive cause of the reported balloon leak and observed damages could not be determined; therefore, an assignable cause of undeterminable was assigned.

Event Description

It was reported that the balloon leaked air during the procedure.There were no reported clinical consequences to the patient.

• Brand Name: FG GATEWAY OTW OUS 2.00MM X 15MM
• Type of Device: CATHETER, BALLOON TYPE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• Manufacturer (Section G): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• Manufacturer Contact: tara lopez ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7175706
• MDR Text Key: 96771038
• Report Number: 3008853977-2018-00001
• Device Sequence Number: 1
• Product Code: GBA
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: H050001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2020
• Device Catalogue Number: M0032072415200
• Device Lot Number: 20636410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SYNCHRO GUIDEWIRE(STRYKER)
• Patient Age: 60 YR
• Patient Weight: 170