MAUDE Adverse Event Report: BOSTON SCIENTIFIC RIGID PNEUMATIC PROBE

Model Number M0068407330

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Information (3190)

Event Date 08/15/2018

Event Type  malfunction  

Event Description

Upon initial use of the boston scientific 1.00mm x 570mm rigid pneumatic probe, the thumb wheel would not move the tip of the probe.As the st at the field was troubleshooting the problem, it was discovered that the black shaft located near the thumb wheel was broken.The device was replaced with a "like" device, which was then utilized without incident to complete the procedure.

• Brand Name: RIGID PNEUMATIC PROBE
• Type of Device: PROBE
• Manufacturer (Section D): BOSTON SCIENTIFIC; marlborough MA 01752
• MDR Report Key: 7851029
• MDR Text Key: 119645653
• Report Number: MW5079632
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2021
• Device Model Number: M0068407330
• Device Catalogue Number: M0068407330
• Device Lot Number: 22301402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR