MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DREAMTOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00584040

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 Description

It was reported to boston scientific corporation that a dreamtome rx 44 was used in the duodenum and papilla of vater during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2020.According to the complainant, during the procedure, the cutting wire orientation was incorrect with respect to the plastic tip.The procedure was completed with another of the same 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 stable.

Event Description

It was reported to boston scientific corporation that a dreamtome rx 44 was used in the duodenum and papilla of vater during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the cutting wire orientation was incorrect with respect to the plastic tip.The procedure was completed with another of the same 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 stable.

Manufacturer Narrative

Block h6 (device codes): problem code 3009 captures the reportable event of cutting wire orientation.Block h10: the returned dreamtome was analyzed, and a visual evaluation noted that the exposed cutting wire was bent, also the wire was detached from the active cord; consequently.The device was disassemble and the 2-1 connector was removed in order to check the connection of the wire and the aluminum disk was not present inside the active cord causing the wire detachment and disabling the orientation performance.The reported event was confirmed.According to the product analysis, the wire of the returned device was detached from the active cord so the 2-1 connector was removed and was found that the aluminum disk was missing letting the wire without tension, this condition caused the wire goes out and it will bend.Based on all gathered information, the most probable cause of this complaint is manufacturing deficiency.An investigation to address this issue has been completed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A search of the complaint database confirmed that no similar complaints exist for the specified lot.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

• Brand Name: DREAMTOME RX 44
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10217710
• MDR Text Key: 197139786
• Report Number: 3005099803-2020-02539
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729778264
• UDI-Public: 08714729778264
• Combination Product (y/n): N
• PMA/PMN Number: K013153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2023
• Device Model Number: M00584040
• Device Catalogue Number: 8404
• Device Lot Number: 0025079151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Date Manufacturer Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR