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

Model Number	24695
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8469926
• Report Number: 2134265-2019-03259
• Device Sequence Number: 13898448
• Product Code: DTL
• UDI-Device Identifier: 08714729190493
• UDI-Public: 08714729190493
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K951089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2019

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 04/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1