MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXTRACTOR PRO RX; CATHETER, BILIARY, DIAGNOSTIC

Model Number M00547000

Device Problem Difficult to Advance (2920)

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

Event Date 06/30/2022

Event Type  malfunction  

Event Description

Note: this report pertains to a dreamtome rx 44 and an extractor pro rx that were used in the same procedure.It was reported to boston scientific corporation that a dreamtome rx 44 and an extractor pro rx were used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, it was noticed that there was a lot of resistance when advancing the preloaded guidewire through the tome.The guidewire kept on getting stuck in the tome.When the guidewire was used with the extractor pro rx, it also slipped out of the c-channel.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a device analysis could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: EXTRACTOR PRO RX
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15099706
• MDR Text Key: 304339838
• Report Number: 3005099803-2022-03952
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729790266
• UDI-Public: 08714729790266
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K102082
• 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
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2024
• Device Model Number: M00547000
• Device Catalogue Number: 4700
• Device Lot Number: 0029026613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2022
• 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