MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JETSTREAM PV31300; CATHETER, PERIPHERAL, ATHERECTOMY

Lot Number 29808835

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/23/2022

Event Type  malfunction  

Event Description

In operating room 12 (twelve) the jetstream tip broke off in the patient's right leg.The tip was retrieved and procedure continued.Rep was notified.Fda safety report id# (b)(4).

• Brand Name: JETSTREAM PV31300
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; marlborough MA
• MDR Report Key: 15498854
• MDR Text Key: 300789074
• Report Number: MW5112295
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/23/2022

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 Operator: Health Professional
• Device Lot Number: 29808835
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 31 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White