MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN FG GATEWAY OTW OUS 3.25MM X 9MM; CATHETER, BALLOON TYPE

Catalog Number M0032072409320

Device Problems Air Leak (1008); Material Rupture (1546)

Patient Problem No Patient Involvement (2645)

Event Date 03/02/2016

Event Type  malfunction  

Manufacturer Narrative

Subject device is not available.

Event Description

It was reported that as suction with the syringe was being performed during preparation of the balloon catheter, an air leak was observed on the balloon.There was no patient involvement.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.Visual examination of the returned device revealed that the balloon was ruptured and the balloon catheter was kinked.The found catheter kink is most likely unrelated to the balloon failure because these appear to be separate failures.The reported complaint of balloon leak was confirmed based on the information provided and investigation.The device failed to meet specifications when received.Since the user reported that the leak occurred during preparation, it is likely that handling damage contributed to the reported and observed damages limiting the performance of balloon before the clinical procedure.Therefore, an assignable cause of operational context has been assigned to this investigation.

Event Description

It was reported that as suction with the syringe was being performed during preparation of the balloon catheter, an air leak was observed on the balloon.There was no patient involvement.

• Brand Name: FG GATEWAY OTW OUS 3.25MM X 9MM
• 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: 5536497
• MDR Text Key: 41522686
• Report Number: 3008853977-2016-00117
• 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: 03/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2016
• Device Catalogue Number: M0032072409320
• Device Lot Number: 16409041
• 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: 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2013
• 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: 67 YR
• Patient Weight: 70