MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) AUTOTOME¿ RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00545180

Device Problem No Apparent Adverse Event (3189)

Patient Problems Death (1802); Inflammation (1932)

Event Date 04/03/2018

Event Type  Death  

Manufacturer Narrative

(b)(6).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report# 3005099803-2018-01311 for the autotome, and 3005099803-2018-01334 for the dreamwire.It was reported to boston scientific corporation that an autotome¿ rx 44 and dreamwire were used in the biliary tree during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, during the procedure, cannulation was difficult and prolonged due to the dreamwire occasionally going into the pancreas.Cannulation was achieved and the dreamwire was advanced into the common bile duct (cbd), a cholangiogram was performed, and a sphincterotomy was performed.They decided to exchange the autotome and remove it from the dreamwire; however, resistance was met.The wire was looping out of the biopsy cap under the locking device; however, the wire was locked to the device.This happened 2 -3 times.After several attempts, the autotome could not be removed from the dreamwire and both devices were removed.Upon examination, the ptfe coating was stripped near the tip of the dreamwire, in the area where the guidewire was snagging on the biopsy cap/locking device.A new autotome and new guidewire were opened and cannulation was attempted again; however, the ampulla was swollen which prevented cannulation.Because they were unable to cannulate, a stent could not be placed and the patient was left with contrast in the biliary system.Reportedly the patient got pancreatitis two days later and the patient died three days after the procedure.According to the complainant, the pancreatitis and subsequent death was not device related.Reportedly, the inability to place a stent due to difficult cannulation contributed to the development of the pancreatitis.

• Brand Name: AUTOTOME¿ RX 44
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7497814
• MDR Text Key: 107691435
• Report Number: 3005099803-2018-01311
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729444756
• UDI-Public: 08714729444756
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K013153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2020
• Device Model Number: M00545180
• Device Catalogue Number: 4518
• Device Lot Number: 21297147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2017
• 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 Outcome(s): Death
• Patient Age: 92 YR