MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ZERO TIP¿; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number M0063901030

Device Problem Difficult to Open or Close (2921)

Patient Problem Perforation (2001)

Event Date 06/27/2017

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.The complainant indicated that the device has been disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a zero tip¿ stone retrieval basket was used in the kidney during a flexible ureteroscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the basket failed to release the stone and was stuck inside the patient.The wire from the handle was cut but still failed to release the stone.The stone was finally removed from the patient by pulling the basket.However, doing so ripped the ureter.The physician repaired the ureter with stitches.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: ZERO TIP¿
• Type of Device: DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6825262
• MDR Text Key: 83833428
• Report Number: 3005099803-2017-02515
• Device Sequence Number: 1
• Product Code: FFL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0063901030
• Device Catalogue Number: 390-103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention