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

Model Number M00584170

Device Problem Failure to Align (2522)

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

Event Date 12/10/2021

Event Type  malfunction  

Manufacturer Narrative

The reported batch 20230311 does not match with the reported upn m00584170.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; 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 Description

It was reported to boston scientific corporation that a truetome 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During endoscopic sphincterotomy (est) procedure, the cutting wire was stuck.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.The reported event may suggest that the cutting wire did not release the bow after being bowed.

Manufacturer Narrative

Block h6 (device codes): medical device problem code a050701 captures the reportable event of cutting wire unable to unbow.Block h6 (evaluation conclusion codes): conclusion code d17 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 problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h2 (additional information): block d4 (lot number, expiration date) and block h4 (device manufacture date) have been updated based on the additional information received on march 31, 2022.

Event Description

It was reported to boston scientific corporation that a truetome 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During endoscopic sphincterotomy (est) procedure, the cutting wire was stuck.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.The reported event may suggest that the cutting wire did not release the bow after being bowed.

• 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: 13171788
• MDR Text Key: 287020650
• Report Number: 3005099803-2022-00009
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729827634
• UDI-Public: 08714729827634
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K122203
• 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: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2023
• Device Model Number: M00584170
• Device Catalogue Number: 8417
• Device Lot Number: 0026957780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 61 YR