MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUETOME 39; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00584190

Device Problem Break (1069)

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

Event Date 08/17/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a truetome 39 was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2022.During the procedure, it was noticed that the cutting wire of the truetome 39 was missing as the device had no cutting wire at all.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(4).The device has not been received for analysis.Upon receipt and completion of the device analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6 (device codes): medical device problem code a0401 captures the reportable event of cutting wire broken.Block h10: the returned truetome 39 was analyzed, and a visual evaluation noted that the device did not have cutting wire out of the extrusion.The device was observed under magnification, and the cutting wire was inside the catheter and a double piercing hole was observed at the proximal section.Additionally, after cutting the extrusion, it was noticed that the anchor was joint to the cutting wire.Functionally, when the handle was actuated, the device did not bow due to the device condition (the cutting wire was inside the catheter).No other problems with the device were noted.The reported event of cutting wire break was not confirmed.Upon analysis, it was found that the cutting wire was inside the catheter, and it did not bow due to its condition.Based on all gathered information, this complaint will be document as manufacturing deficiency.An investigation to address this problem has been initiated.

Event Description

It was reported to boston scientific corporation that a truetome 39 was used in the papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, it was noticed that the cutting wire of the truetome 39 was missing as the device had no cutting wire at all.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: TRUETOME 39
• 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: 15372862
• MDR Text Key: 299472928
• Report Number: 3005099803-2022-05096
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729827658
• UDI-Public: 08714729827658
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 11/01/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2024
• Device Model Number: M00584190
• Device Catalogue Number: 8419
• Device Lot Number: 0029007944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/07/2022
• Supplement Dates Manufacturer Received: 10/14/2022
• Supplement Dates FDA Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2022
• 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