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

Model Number	M00584060
Medical Device Problem Codes	Failure to Align (2522); Material Deformation (2976); Material Twisted/Bent (2981); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device is not available for return; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a dreamtome rx 44 was used in the biliary ducts during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, "the cutting line moved a lot and the station wagon did not stay in place properly.The system stretched and relaxed." when the physician pressed the pedal energizing the device to cut the papilla, it was noticed that the cutting wire was completely twisted.It was reported that the orientation of cutting wire and the catheter were both incorrect.Additionally, the entire length of the cutting wire was completely bent and unusable.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.The reported event may suggest that the orientation of the cutting wire was incorrect.

• Brand Name: DREAMTOME RX 44
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12830171
• Report Number: 3005099803-2021-05709
• Device Sequence Number: 19212510
• Product Code: KNS
• UDI-Device Identifier: 08714729778288
• UDI-Public: 08714729778288
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K013153
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2021

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: 06/23/2024
• Device Model Number: M00584060
• Device Catalogue Number: 8406
• Device Lot Number: 0027553568
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 11/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown