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

Model Number M00545180

Device Problem Failure to Align (2522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure 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 an autotome rx 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, the tomes was taken out of the package bowed and it would not "bow down enough" to fit through the scope.The procedure was completed.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block h6 (device codes): the problem code 2522 captures the reportable event of cutting wire failure to release bow.Block h10: the returned autotome rx 44 was analyzed, and a visual evaluation noted that the working length was bent in the distal section and twisted in the proximal section.Additionally, the exposed cutting wire was bent.A functional evaluation noted that the device was able to bow and release from bow as intended inside and outside of the scope.No other problems with the device were noted.The reported complaint was not confirmed.Upon analysis, it was found that the device bowed and released from bow as intended.Additionally, the cutting wire was bent and the working length was twisted and bent.Based on the condition of the device, the problems found could have been caused by the manipulation of the device during advancing into the scope or if the device was hit against a hard surface.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 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, the tomes was taken out of the package bowed and it would not "bow down enough" to fit through the scope.The procedure was completed.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.

• Brand Name: AUTOTOME RX 44
• 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: 10581690
• MDR Text Key: 208416410
• Report Number: 3005099803-2020-04184
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729444756
• UDI-Public: 08714729444756
• Combination Product (y/n): N
• PMA/PMN Number: K013153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

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: 06/29/2023
• Device Model Number: M00545180
• Device Catalogue Number: 4518
• Device Lot Number: 0025653046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/24/2020
• Supplement Dates Manufacturer Received: 10/27/2020
• Supplement Dates FDA Received: 11/20/2020
• Patient Sequence Number: 1