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

Model Number	M00535700
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a tandem¿ xl was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, it was noted that there was no radiopaque (ro) marker on the tip of the tandem.The procedure was completed with this device.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 good.
Additional Manufacturer Narrative
A visual examination of the returned device found that the radiopaque (ro) marker was not present and not returned for analysis.No damages or torn sections were noted on any section of the product; therefore, the tip of the device was cut in half and no witness marks were present, indicating that the device was not properly manufactured (the ro marker was not placed into the extrusion).It was found during the investigation of the returned tandem xl that the ro marker was not present and not returned for analysis; consequently, confirming the reported complaint.Based on the information available and the analysis performed, the complaint investigation conclusion code selected is manufacturing execution error.An investigation is in place to address this issue.A dhr (device history record) review was performed and no deviation was found.
Event or Problem Description
It was reported to boston scientific corporation that a tandem xl was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, it was noted that there was no radiopaque (ro) marker on the tip of the tandem.The procedure was completed with this device.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 good.

• 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: 7663273
• Report Number: 3005099803-2018-02229
• Device Sequence Number: 16773081
• Product Code: KOG
• UDI-Device Identifier: 08714729146636
• UDI-Public: 08714729146636
• 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,Followup
• Report Date (Section B): 06/13/2018

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: 02/13/2020
• Device Model Number: M00535700
• Device Catalogue Number: 3570
• Device Lot Number: 21738422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1