MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OCCLUDER; CATHETER, UROLOGICAL

Model Number	M0062201070
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Fever (1858); Pain (1994)
Date of Event	04/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to report the device lot number; therefore the manufacture date and expiration date are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an occluder balloon catheter was used during a ureteroscopic stone retrieval procedure performed on (b)(6) 2016.On (b)(6) 2016, the patient underwent a ureteroscopic stone retrieval procedure and the occluder tube was left inside the patient when she was discharged on (b)(6) 2018 due to ureteric obstruction.Whilst recovering at home, it was noticed that the tube was draining less.By (b)(6) 2016 the device had completely stopped draining.The patient attended a&e on (b)(6) 2016 with pain and a fever.The patient was then admitted to the hospital and a nephrostogram was performed on (b)(6) 2016.This showed that the device had fractured.The tube remained in the kidney but was not connected to the drainage bag.The tube was removed via laparoscopy the same day.It was replaced with a new tube that drained well.The patient was discharged home and a good recovery was made, with the tube being removed on (b)(6) 2016.The patient current condition and prognosis is under investigation.The patient continues to suffer with back pain and has significant scarring from the need for a further operation.

• Brand Name: OCCLUDER
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8226072
• Report Number: 3005099803-2018-62433
• Device Sequence Number: 13959890
• Product Code: EYB
• UDI-Device Identifier: 08714729191988
• UDI-Public: 08714729191988
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K133750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2019

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
• Operator of Device: Health Professional
• Device Model Number: M0062201070
• Device Catalogue Number: 220107
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 01/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR