MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP TRAPEZOID RETRIEVAL BASKET; LITHOTRIPTOR, BILIALY MECHANICAL

Model Number MOO510870

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Pneumonia (2011); Thrombus (2101)

Event Date 12/05/2018

Event Type  Injury  

Event Description

During ecrp the retrieval basket broke off requiring exploratory laparotomy to remove basket.Patient with post-operative complications i.E.Blood clot, pneumonia, drains and prolonged hospitalization.

• Brand Name: TRAPEZOID RETRIEVAL BASKET
• Type of Device: LITHOTRIPTOR, BILIALY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP; marlborough MA 01752
• MDR Report Key: 8377978
• MDR Text Key: 137573691
• Report Number: MW5084479
• Device Sequence Number: 1
• Product Code: LQC
• 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: 02/26/2019

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: MOO510870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2019
• 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 Outcome(s): Hospitalization
• Patient Age: 88 YR
• Patient Weight: 64