MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL; DISLODGER, STONE, FLEXIBLE

Model Number M0063903200

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual analysis revealed that the device was returned closed.The blue sheath overran the distal stop, affecting the devices' ability to open.The blue/green shrink on the distal end of the cone was missing and was not returned.Also, the white heat shrink was found accordioned at the proximal end.Since the complaint is associated with a product which met specifications but most likely encountered anatomical or procedural factors which limited its performance, the most probable root cause for this event is operational context.The device history record (dhr) review found the device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the ureter during a transurethral ureterolithotripsy (tul) procedure performed on an unknown date.According to the complainant, during the procedure, the coil of the stone cone failed to open.The procedure was completed by another of the same device.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 "good." this event has been deemed a reportable event based on the investigation results; coil coating peeled.

• Brand Name: STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL
• Type of Device: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): ACCELLENT ENDOSCOPY JUAREZ; 31c butterfield trail; el paso TX 79906
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6719837
• MDR Text Key: 80257417
• Report Number: 3005099803-2017-02020
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: (01)08714729430223(17)20190725(10)F69386
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2019
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: F69386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2016
• 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