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

Model Number M00584040

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a dreamtome rx 44 was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) with possible stone removal procedure performed on (b)(6) 2022.During the procedure, the physician had difficulty cannulating due to the patient's ampulla anatomy which was positioned at 12 o'clock.Since the cannulation was unsuccessful, a needle knife was used to perform the sphincterotomy.The first dreamtome rx 44 was then reloaded into the duodenoscope and cannulation was attempted again.After approximately thirty minutes of attempts of cannulation, the cutting wire of the dreamtome rx 44 broke.It was reported that no part of the cutting wire detached and fell into the patient.A second dreamtome rx 44 was opened and used to cannulate to gain access into the ampulla; however, they still could not gain access due to the patient's anatomy.There was no device deficiency with the needle knife and the second dreamtome rx 44.The procedure was cancelled/rescheduled due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: medical device problem code a0401 captures the reportable event of cutting wire broken.Block h10: the returned dreamtome rx 44 (with its preloaded guidewire) was analyzed, and a visual evaluation noted that the cutting wire was broken.The distal tip of the dreamwire guidewire was bent.The device was observed under magnification, and the cutting wire was broken and blackened.No other problems with the device were noted.The reported event of cutting wire break was confirmed.Upon analysis, it was found that the cutting wire was broken and blackened.The cutting wire being blackened indicates that the device was energized.Based on the condition of the device, the problem found could have been generated if there was contact between the device and the scope during energization or if the generator exceeded the maximum of voltage during the procedure.Also, energizing the device prior to performing sphincterotomy can compromise the cutting wire's integrity and cause a premature cutting wire fatigue.It was also found that the distal tip of the dreamwire guidewire was bent which- could have been due to excess of force was applied to the device during the procedure, such as during the guidewire insertion through the autotome.It is most likely that procedural or anatomical factors encountered during the use of the device could have affected the device performance and its integrity.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that a dreamtome rx 44 was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) with possible stone removal procedure performed on (b)(6) 2022.During the procedure, the physician had difficulty cannulating due to the patient's ampulla anatomy which was positioned at 12 o'clock.Since the cannulation was unsuccessful, a needle knife was used to perform the sphincterotomy.The first dreamtome rx 44 was then reloaded into the duodenoscope and cannulation was attempted again.After approximately thirty minutes of attempts of cannulation, the cutting wire of the dreamtome rx 44 broke.It was reported that no part of the cutting wire detached and fell into the patient.A second dreamtome rx 44 was opened and used to cannulate to gain access into the ampulla; however, they still could not gain access due to the patient's anatomy.There was no device deficiency with the needle knife and the second dreamtome rx 44.The procedure was cancelled/rescheduled due to this event.There were no patient complications reported as a result of this event.

• 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
• 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: 14429032
• MDR Text Key: 292391218
• Report Number: 3005099803-2022-02722
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729778264
• UDI-Public: 08714729778264
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K013153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00584040
• Device Catalogue Number: 8404
• Device Lot Number: 0028667939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1