MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER TANDEM¿ XL; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	M00535700
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	05/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a tandem xl cannula was used in the colon during a colon stent placement procedure performed on (b)(6) 2017.According to the complainant, during preparation, a foreign object was found stuck in the injection port of this device.There was no visible damage noted on the device packaging.This device was not used and the procedure was completed with a second tandem xl cannula.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: TANDEM¿ XL
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6668072
• Report Number: 3005099803-2017-01811
• Device Sequence Number: 16578208
• Product Code: KOG
• UDI-Device Identifier: 08714729146636
• UDI-Public: (01)08714729146636(17)20190228(10)20320053
• Combination Product (Y/N): N
• PMA/510(K) Number: K833417
• 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): 05/29/2017

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: 02/28/2019
• Device Model Number: M00535700
• Device Catalogue Number: 3570
• Device Lot Number: 20320053
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2017
• Initial Report FDA Received Date: 06/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1