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

Model Number	M0063903100
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 a stone cone nitinol urological retrieval coil was used in the ureter on a procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the stone cone retrieval device failed to retract into the sheath.The retrieval device was removed together with the scope from the patient's body.However, when the device was removed it was found the tip broke and detached.A grasping forceps was used to retrieved the detached tip.Fluoroscopy confirmed that no device fragments are left inside the patient.Additionally, it was reported that a laser was used during the procedure but it did not damage the retrieval device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
A visual analysis of the returned device found that the coil is detached proximal to the distal stop.The rest of the coil is burnt and broken is several places but still attached to the device by the blue/green heat shrink.There are burn marks at the breaks.The blue sheath is detached and was not returned.Review and analysis of all available information indicates that there was an evidence of scorching which was most likely caused by the laser during the procedure.Therefore, the most probable root cause is "caused by other device" since the investigation indicates another device/drug/subsequent procedure caused the complaint event.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.A labeling review was performed and no anomaly was found.
Event or Problem Description
It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the ureter on a procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the stone cone retrieval device failed to retract into the sheath.The retrieval device was removed together with the scope from the patient's body.However, when the device was removed it was found the tip broke and detached.A grasping forceps was used to retrieved the detached tip.Fluoroscopy confirmed that no device fragments are left inside the patient.Additionally, it was reported that a laser was used during the procedure but it did not damage the retrieval device.There were no patient complications reported as a result of this event.

• Brand Name: STONE CONE NITINOL UROLOGICAL RETRIEVAL COIL
• Common Device Name: DISLODGER, STONE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 6731037
• Report Number: 3005099803-2017-02080
• Device Sequence Number: 13658394
• Product Code: FGO
• UDI-Device Identifier: 08714729430209
• UDI-Public: (01)08714729430209(17)20190609(10)F52633
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2017

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 Expiration Date: 06/09/2019
• Device Model Number: M0063903100
• Device Catalogue Number: 390-310
• Device Lot Number: F52633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Initial Date Received by Manufacturer: 06/26/2017
• Supplement Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 08/17/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention