MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GATEWAY PLUS; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

Model Number 24695

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr.: the device was returned for evaluation.The device returned with its original pouch, the pouch was opened and the device was out of it.A visual inspection on the device revealed that there was a small piece of a foreign matter that looks like plastic within the device, the device was not cracked.

Event Description

Reportable based on device analysis completed on (b)(6) 2019.It was reported that there was a crack on the device.A 10pk gateway plus was selected for use.During the preparation, it was noted that there was a crack on the device.The procedure was completed with another of the same device.There were no patient complications reported.However,a analysis revealed that there was a small piece of a foreign matter that looks like plastic and it caused an optical effect that seemed to be a crack in the device material.

• Brand Name: GATEWAY PLUS
• Type of Device: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road,; cork ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8469926
• MDR Text Key: 140498641
• Report Number: 2134265-2019-03259
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 08714729190493
• UDI-Public: 08714729190493
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K951089
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2020
• Device Model Number: 24695
• Device Catalogue Number: 24695
• Device Lot Number: 0022888496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2018
• 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