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 11/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Lake region medical- (b)(4).The device has not been received for analysis.Upon receipt and 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 Description

It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the kidney, during a ureteroscopy with lithotripsy procedure.The procedure was performed on (b)(6) 2017.According to the complainant, during the procedure when the device was removed from the patient, it was noticed that the device was fragmented.Another ureteroscopy was performed and a piece of the blue plastic cover was observed inside the patient.The procedure was completed using another different device.There is no confirmation if the piece of the blue plastic cover was retrieved.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¿.

Manufacturer Narrative

A visual analysis of the returned device found that the blue sheath is buckled and accordioned in several places along the shaft.The distal end of the blue sheath is torn and appears heat damaged.The distal section of the blue/green heat shrink is accordioned.The exposed coil wire in this area appears heat damaged.Review and analysis of the device shows evidence of heat damage which was most likely caused during the ureteroscopy lithotripsy 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 Description

It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the kidney, during a ureteroscopy with lithotripsy procedure.The procedure was performed on (b)(6) 2017.According to the complainant, during the procedure when the device was removed from the patient, it was noticed that the device was fragmented.Another ureteroscopy was performed and a piece of the blue plastic cover was observed inside the patient.The procedure was completed using another different device.There is no confirmation if the piece of the blue plastic cover was retrieved.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: 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: 7144235
• MDR Text Key: 95695953
• Report Number: 3005099803-2017-03820
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430223
• UDI-Public: 08714729430223
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/24/2020
• Device Model Number: M0063903200
• Device Catalogue Number: 390-320
• Device Lot Number: 0003768063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR