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

Model Number M00584190

Device Problems Difficult to Advance (2920); Positioning Problem (3009)

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

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(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 truetome 39 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During procedure, the nurse experienced difficulty loading the jagwire revolution guidewire through the guidewire port of the truetome 39.Additionally, there was difficulty advancing the guidewire through the tome.It was reported that the tip of the guidewire was activated using saline.When the truetome 39 was inserted into the scope, the direction of the catheter tip and the direction of the cutting wire, with respect to the plastic tip, were not correct.The orientation was observed to be at the 9 o'clock position.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a truetome 39 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During procedure, the nurse experienced difficulty loading the jagwire revolution guidewire through the guidewire port of the truetome 39.Additionally, there was difficulty advancing the guidewire through the tome.It was reported that the tip of the guidewire was activated using saline.When the truetome 39 was inserted into the scope, the direction of the catheter tip and the direction of the cutting wire, with respect to the plastic tip, were not correct.The orientation was observed to be at the 9 o'clock position.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block e1 (initial reporter phone): (b)(6).Block e1 (initial reporter fax): (b)(6).Block h6 (device codes): medical device problem code a1502 captures the reportable event of incorrect cutting wire orientation.Block h10: the returned truetome 39 was analyzed, and a visual evaluation noted that the working length was kinked at the distal section which was consistent to the finding when the device was observed under magnification.A functional evaluation noted that the catheter was correctly oriented when the distal tip was extended approximately 25mm past the elevator of the duodenoscope.Additionally, a guidewire was removed and reinserted through the catheter without a problem.Per media analysis, the picture shows the distal section of the device.There were no damages observed based on the photo.No other problems with the device were noted.The reported event was not confirmed.The device did not have orientation problems.Upon analysis, it was found that the working length was kinked.Based on the condition of the device, the problem found could have been caused due to multiple attempts to rotate the device, or after multiple attempts to activate the bow function or during introduction of the device into the scope.Based on all gathered information and the analysis performed to the returned product, it was concluded that the investigation conclusion code of this event is no problem detected since after product analysis it was not possible to observe the problem reported by the customer.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.Block h11 (correction): section e has been corrected using the nurse's details below as it was the nurse who reported the event.

• 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
• MDR Report Key: 12339511
• MDR Text Key: 267217924
• Report Number: 3005099803-2021-04233
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729827658
• UDI-Public: 08714729827658
• Combination Product (y/n): N
• PMA/PMN Number: K122203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2023
• Device Model Number: M00584190
• Device Catalogue Number: 8419
• Device Lot Number: 0027127932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1