MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO WIREGUIDED BALLOON DILATATION CATHETER; CATHETER, BILIARY, DIAGNOSTIC

Model Number M00558690

Device Problems Inflation Problem (1310); Leak/Splash (1354); Material Rupture (1546)

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

Event Date 02/24/2023

Event Type  malfunction  

Event Description

Reported: inserted the dilation catheter through the endoscope into the patient's esophagus.Inflated the device when directed by the physician to do so.The pressure kept dropping as the catheter was inflated.Notified the physician all water was expelled from the syringe, but the balloon was not inflated as it should be.When i tried to draw the water back into the syringe, nothing came back.We believe the end of the balloon was ruptured.

• Brand Name: CRE PRO WIREGUIDED BALLOON DILATATION CATHETER
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 16520741
• MDR Text Key: 311056503
• Report Number: 16520741
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729797579
• UDI-Public: 08714729797579
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/28/2023

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 Model Number: M00558690
• Device Lot Number: 30053754
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/10/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27740 DA
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Race: White