MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SUCTION TUBING

Model Number	SVT-089-100
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that suction tubing was to be used on a colonoscopy with esophagogastroduodenoscopy (egd) procedure, performed on (b)(6) 2020.According to the complainant, during preparation, a foreign body noticed inside of tubing.The procedure was completed with another suction tubing.There were no patient complications reported as a result of this event.

• Brand Name: SUCTION TUBING
• Common Device Name: SUCTION TUBING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9902549
• Report Number: 3005099803-2020-01329
• Device Sequence Number: 17087741
• Product Code: GAZ
• UDI-Device Identifier: 00816849016788
• UDI-Public: 00816849016788
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2020

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 Model Number: SVT-089-100
• Device Catalogue Number: 2106-01
• Device Lot Number: 0000190906
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR