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

Model Number M00547030

Device Problems Break (1069); Difficult to Advance (2920)

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

Event Date 04/13/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a extractor pro rx retrieval balloon was used in common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the balloon was difficult to pass down the scope.The catheter was noted to snap in half in the patient's common bile duct.The customer stated that they need to sweep the balloon fragment out of the patient.The procedure was not completed and was cancelled after the patient had been sedated.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code a0401 captures the reportable event of catheter break.Impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.

• 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: 16908156
• MDR Text Key: 314972321
• Report Number: 3005099803-2023-02302
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729790280
• UDI-Public: 08714729790280
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102082
• 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
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00547030
• Device Catalogue Number: 4703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Race: White