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

Model Number	M00535700
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date (b)(6) 2019 was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(4).The device has not been received for analysis.Upon receipt and 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 ercp cannula was to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.According to the complainant, during preparation outside of the patient, it was observed that the radiopaque marker band was detached.The procedure was completed with a second tandem xl ercp cannula.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(date of event): the exact date of the event is unknown.The provided event date (b)(6) 2019 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6 (device codes): problem code 2907 captures the reportable event of ro marker band detached.Block h10: visual examination of the returned device revealed that the ro marker band was not found; however, remnants of the internal tip indicating the components was joined prior the separation.Additionally, the tip was found damaged.The complaint was consistent with the reported event of ro marker band detached.It is possible that operational factors, such as user technique/handling during preparation or the interaction with the other device could have contributed with the observed tip damaged and the ro marker band detached since there is enough evidence that the device was manipulated.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release to distribution.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that a tandem xl ercp cannula was to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.According to the complainant, during preparation outside of the patient, it was observed that the radiopaque marker band was detached.The procedure was completed with a second tandem xl ercp cannula.There were no patient complications reported as a result of this event.

• Brand Name: TANDEM XL
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9356949
• Report Number: 3005099803-2019-05732
• Device Sequence Number: 2353574
• Product Code: ODD
• UDI-Device Identifier: 08714729146636
• UDI-Public: 08714729146636
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K833417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2020

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 Expiration Date: 07/21/2021
• Device Model Number: M00535700
• Device Catalogue Number: 3570
• Device Lot Number: 0024145445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1