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

Model Number M00584170

Device Problem Break (1069)

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

Event Date 07/01/2022

Event Type  malfunction  

Manufacturer Narrative

Approximated based on the date the manufacturer became aware of the event.Medical device problem code a0401 captures the reportable event of cutting wire broken.Evaluation conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a device analysis could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a truetome 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure.The exact procedure date was unknown.During the procedure, the cutting wire broke when using cautery.There were no reported patient complications as a result of this event.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block h2 (additional information): block b5, block d7a, block h8 have been updated based on the additional information received on august 26, 2022.Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: medical device problem code a0401 captures the reportable event of cutting wire broken.

Event Description

It was reported to boston scientific corporation that a truetome 44 was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure.The exact procedure date was unknown.During the procedure, the cutting wire broke when using cautery.It was reported that no part of the cutting wire detached and fell into the patient.The procedure was completed with the original truetome 44.There were no reported patient complications as a result of this event.

• Brand Name: TRUETOME 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: 15213079
• MDR Text Key: 304683467
• Report Number: 3005099803-2022-04486
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729827634
• UDI-Public: 08714729827634
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2024
• Device Model Number: M00584170
• Device Catalogue Number: 8417
• Device Lot Number: 0029317134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2022
• 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