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

Catalog Number M0032072415220

Device Problem Air Leak (1008)

Patient Problem No Patient Involvement (2645)

Event Date 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

The subject device is not available.

Event Description

It was reported that during preparation of the balloon catheter an air leak was observed.There was no patient involvement.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.During attempted inflation of the balloon, a leak was noted at the guidewire port and the balloon would not inflate normally.Magnified examination inside the inflation port revealed that the shaft was perforated, which is likely where the leak was occurring.No other anomalies were noted.Although no leaks were found in the balloon section of the subject device, the reported complaint was confirmed as it is possible the user referred to the inner shaft proximal hub leak as a balloon leak.Based on the examination of the damage inside the inflation lumen (balloon port), it appears that the guidewire was inserted into the balloon port (instead of the guidewire lumen), leading to the observed damage and reported leak.Per the device directions for use (dfu): ¿introduce the guidewire, flexible-end first, into the straight (back) port of the manifold.To avoid kinking, advance the guidewire slowly in small increments to the end of the balloon catheter.¿ additionally, the dfu provides a diagram which shows the balloon port and guidewire port.Previous discussions with manufacturer (boston scientific, (b)(4)), have confirmed that the manufacturing process has associated controls related to manifold leaks for the gateway devices.These include, 100% visual inspection for balloon/shaft integrity, leak and vacuum decay testing (vdt) prior to packaging.Therefore, it is considered unlikely that the damage noted on the returned unit occurred prior to shipment.Review of the reported information, product analysis results, and manufacturing records revealed no evidence of any design or manufacturing specification non-conformances related to the complaint device.Therefore an assignable cause of handling damage has been assigned to this investigation.

Event Description

It was reported that during preparation of the balloon catheter an air leak was observed.There was no patient involvement.

• Brand Name: FG GATEWAY OTW OUS 2.25MM X 15MM
• Type of Device: 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: sanda dracic ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 5533667
• MDR Text Key: 41412732
• Report Number: 3008853977-2016-00114
• 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: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2017
• Device Catalogue Number: M0032072415220
• Device Lot Number: 16905422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2014
• 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
• Patient Age: 70 YR
• Patient Weight: 73