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

Model Number	M00583190
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact date of the event is unknown.The provided event date (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.(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 truetome dreamwire 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure.According to the complainant, during the procedure, the cutting wire broke.The procedure was completed with this device.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be fine.
Event or Problem Description
It was reported to boston scientific corporation that a truetome dreamwire 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure.According to the complainant, during the procedure, the cutting wire broke.The procedure was completed with this device.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be fine.***additional information (b)(6) 2020*** reportedly, the complainant believes the issue is related to the generator that was used.They had recently switched to a new generator, and they had an issue with repeated cutting wire breaks since they started using the new generator.After switching back to the previous generator, the issue resolved.In addition, cutting wire detachment also occurred when the suspect generator was tested with non-bsc sphincterotomes.
Additional Manufacturer Narrative
Additional information: b5 block b3 (date of event): the exact date of the event is unknown.The provided event date (b)(6)2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block d4, h4: the complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.Block h6 (device codes): the problem code 1069 captures the reportable event of cutting wire broken.Block h6(evaluation conclusion codes): conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.
Additional Manufacturer Narrative
Additional information: b5.Block b3 (date of event): the exact date of the event is unknown.The provided event date (b)(6) 2020 was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block d4, h4: the complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.Block h6 (device codes): the problem code 1069 captures the reportable event of cutting wire broken.Block h6(evaluation conclusion codes): conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure 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 truetome dreamwire 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure.According to the complainant, during the procedure, the cutting wire broke.The procedure was completed with this device.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be fine.***additional information 09mar2020*** reportedly, the complainant believes the issue is related to the generator that was used.They had recently switched to a new generator, and they had an issue with repeated cutting wire breaks since they started using the new generator.After switching back to the previous generator, the issue resolved.In addition, cutting wire detachment also occurred when the suspect generator was tested with non-bsc sphincterotomes.***additional information 11aug2020*** reportedly, the suspect generator had been picked up from the account and tested; and it worked as intended.The same generator and connection cables were sent back to the account after testing, and since then no further complaints have been reported.Additionally, the nurse confirmed that the right generator settings were used during the procedure.

• Brand Name: TRUETOME DREAMWIRE 44
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9772196
• Report Number: 3005099803-2020-00671
• Device Sequence Number: 2704313
• Product Code: KNS
• UDI-Device Identifier: 08714729858737
• UDI-Public: 08714729858737
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K122203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2020

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 Model Number: M00583190
• Device Catalogue Number: 47407
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 03/09/2020; 08/11/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 04/03/2020; 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1