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

Model Number M00545190

Device Problem Positioning Problem (3009)

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

Event Date 11/16/2021

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an autotome rx 39 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, when the device exited the scope, it was noticed that the orientation of the catheter and cutting wire were both incorrect.It was reported that the cutting wire appeared to be wrapped under the tome.There was no visible damage to the device prior to putting it through the scope and after the problem occurred.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

(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.

Manufacturer Narrative

Block h6 (device codes): medical device problem code a1502 captures the reportable event of incorrect cutting wire orientation.Block h10: the returned autotome rx 39 was analyzed, and a visual evaluation noted that the working length was twisted.The tip was observed under magnification, and the tip was twisted.A functional evaluation was performed by introducing the device into the scope, and when the distal tip was extended approximately 25mm past the elevator of the duodenoscope, the catheter was not correctly oriented due to the twist.No other problems with the device were noted.Upon analysis, it was found that the working length was twisted.Based on the condition of the device, the problem found could have been generated due to multiple attempts of rotating the device or during introduction of the device into the scope.This condition could have led to incorrect orientation of the catheter, consequently to incorrect orientation of the cutting wire.Based on all gathered information, the most probable root cause of this complaint is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that an autotome rx 39 was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the procedure, when the device exited the scope, it was noticed that the orientation of the catheter and cutting wire were both incorrect.It was reported that the cutting wire appeared to be wrapped under the tome.There was no visible damage to the device prior to putting it through the scope and after the problem occurred.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

• Brand Name: AUTOTOME RX 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: 12931401
• MDR Text Key: 286952363
• Report Number: 3005099803-2021-06241
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729444763
• UDI-Public: 08714729444763
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00545190
• Device Catalogue Number: 4519
• Device Lot Number: 0028042376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2021
• 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
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 54 KG
• Patient Race: White