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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER ZERO TIP¿ DISLODGER, STONE, BASKET, URETERAL, METAL

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BOSTON SCIENTIFIC - SPENCER ZERO TIP¿ DISLODGER, STONE, BASKET, URETERAL, METAL Back to Search Results
Model Number M0063901050
Device Problem Difficult to Open or Close (2921)
Patient Problem Hemorrhage/Bleeding (1888)
Event Type  Injury  
Manufacturer Narrative
A visual examination of the returned device found the basket was in opened/extended position when received, and the basket was in good condition without evidence of damage. The distal end of the sheath was stretched out of specification. The handle cannula was found broken at its proximal end. A torque mark was present on the handle cap, indicating proper torque during assembly. Additionally, an indentation mark was found in the handle indicating correct assembly during the manufacturing process. A functional evaluation was performed, and the handle was actuated in both positions. The basket would not close due to the handle cannula being broken. The evaluation concluded that during the procedure, excessive manipulation of the device, interaction with the scope, and/or other devices could most likely contribute to the issues found. Also, anatomical and/or procedural factors during the procedure could have increased the resistance within the working length, directly affecting the device performance. The reason for the difficulty releasing the stone cannot be determined; however, the damage observed is likely due to attempts to open/close the basket or to retrieve the stone by pulling the device. Therefore taking into consideration all these factors, the most probable root cause of this complaint will be documented as ¿operational context¿. The device history record review found the device met all manufacturing specifications. A search of the complaint database revealed that no similar complaints exist for the specified lot. A labeling review was performed and no anomaly was found.
 
Event Description
It was reported to boston scientific corporation that a zero tip¿ stone retrieval basket was used in the ureter during a kidney stone removal procedure. According to the complainant, during the procedure, a zero tip¿ stone retrieval basket was used to capture a 7 mm stone. The basket had difficulty releasing the stone and did not disengage properly, but eventually the stone was able to be released. While removing the device from the ureter, it appeared that some tissue had caught and significant bleeding occurred. The physician was concerned about a ureteric injury, and was unable to confirm ureteric continuity, therefore the patient was sent to royal perth hospital for nephrostomy tube insertion. The patient's condition at the conclusion of the procedure was reported to be stable.
 
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Brand NameZERO TIP¿
Type of DeviceDISLODGER, STONE, BASKET, URETERAL, METAL
Manufacturer (Section D)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
Manufacturer (Section G)
BOSTON SCIENTIFIC - SPENCER
780 brookside drive
spencer IN 47460
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key6651062
MDR Text Key77879821
Report Number3005099803-2017-01803
Device Sequence Number1
Product Code FFL
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 05/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2019
Device Model NumberM0063901050
Device Catalogue Number390-105
Device Lot Number20164607
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/16/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/19/2017 Patient Sequence Number: 1
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