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 Date 07/01/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2018 as no event date was reported.(b)(4).Investigation results: a stone cone retrieval coil was received for analysis.A visual analysis of the returned device found that the blue/green shrink is damaged, most likely from handling near the distal end preventing the device from closing completely.A functional evaluation found the device will open freely but will not close completely.The complaint that the device could not open was not confirmed.Investigation analysis revealed that the device could not close, and had coil coating- peeled/shared/frayed.Since the damage occurred during preparation, the root cause for this event is handling damage.The complaint was caused by handling of the device or portion of the device without direct patient contact either during unpacking, preparation, or shipping; at the end of the procedure; or when packaging for return.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A search of the complaint database confirmed that no similar complaints exist for the specified batch.

Event Description

It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in a transuretheral lithotripsy procedure performed in the ureter, on an unknown date.According to the complainant, during introduction a functional check test was performed.The stone cone was able to be straightened after it coiled.When trying to insert and deploy the device, there was reported to be considerable resistance and deployment could not be performed.The procedure was completed with another stone cone.The 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 no patient injury.This event has been deemed a reportable event based on the investigation findings of: coil/cone coating peeled/shared/frayed.

• 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 Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7986674
• MDR Text Key: 124513489
• Report Number: 3005099803-2018-02615
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• 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: Physician
• Type of Report: Initial
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2020
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0003903210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2018
• Initial Date FDA Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2017
• 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