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

Model Number M0063903100

Device Problems Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)

Event Date 01/10/2018

Event Type  Injury  

Manufacturer Narrative

(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 an unknown procedure on an unknown date.According to the complainant, during the procedure, a 270 micron laser fiber was used to fragment a stone positioned under the coil.However, the distal portion of the coil broke off and migrated to the lower calyx of the left kidney making visualization of the broken portion difficult.The broken portion of the cone eventually migrated to the left iliolumbar ureter and another urethroscopy for extraction was performed.A month after the procedure, during follow-up visit, a kidney scan was performed and a foreign body was found in the kidney.On (b)(6) 2018, a procedure was performed to remove the piece of the stone cone from the patient¿s kidney.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 ¿no problem¿.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

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 Description

It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the kidney during an unknown procedure on an unknown date.According to the complainant, during the procedure, a 270 micron laser fiber was used to fragment a stone positioned under the coil.However, the distal portion of the coil broke off and migrated to the lower calyx of the left kidney making visualization of the broken portion difficult.The broken portion of the cone eventually migrated to the left iliolumbar ureter and another urethroscopy for extraction was performed.A month after the procedure, during follow-up visit, a kidney scan was performed and a foreign body was found in the kidney.On (b)(6) 2018, a procedure was performed to remove the piece of the stone cone from the patient¿s kidney.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 ¿no problem¿.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Additional information received as of 30mar2018.The patient underwent a ureteral endoscopic procedure on (b)(6) 2018, where a 270 micron laser fiber was used to break a stone and the coil behind the stone ruptured.It migrated into the lower calyx of the left kidney.A month after, the patient experienced discomfort and lumbar pain.A ct scan was performed and revealed that a fragmented portion of the stone cone had migrated into the lumbar part of the left ureter.

Manufacturer Narrative

Investigation results: a stone cone was received for analysis.A visual analysis of the device revealed that the distal portion of the coil with the distal stop and ball weld, was returned separated from the device.A burn mark was found on the blue green shrink indicating that the device was scorched.The complaint was confirmed.The root cause for this complaint is "caused by other", since the device shows evidence of scorching which was caused by laser during the procedure.A root cause of caused by other is used when the investigation indicates another device/drug/subsequent procedure caused the complaint event.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 revealed that no similar complaints exist for the specified lot.A labeling review was performed and no anomalies were found.

Event Description

It was reported to boston scientific corporation that a stone cone nitinol urological retrieval coil was used in the kidney during an unknown procedure on an unknown date.According to the complainant, during the procedure, a 270 micron laser fiber was used to fragment a stone positioned under the coil.However, the distal portion of the coil broke off and migrated to the lower calyx of the left kidney making visualization of the broken portion difficult.The broken portion of the cone eventually migrated to the left iliolumbar ureter and another urethroscopy for extraction was performed.A month after the procedure, during follow-up visit, a kidney scan was performed and a foreign body was found in the kidney.On (b)(6) 2018, a procedure was performed to remove the piece of the stone cone from the patient¿s kidney.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 ¿no problem¿.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.The patient underwent a ureteral endoscopic procedure on (b)(6) 2018, where a 270 micron laser fiber was used to break a stone and the coil behind the stone ruptured.It migrated into the lower calyx of the left kidney.A month after, the patient experienced discomfort and lumbar pain.A ct scan was performed and revealed that a fragmented portion of the stone cone had migrated into the lumbar part of the left ureter.

• 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
• MDR Report Key: 7381660
• MDR Text Key: 103827146
• Report Number: 3005099803-2018-00943
• Device Sequence Number: 1
• Product Code: FGO
• UDI-Device Identifier: 08714729430209
• UDI-Public: 08714729430209
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2020
• Device Model Number: M0063903100
• Device Catalogue Number: 390-310
• Device Lot Number: 0003768067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Initial Date Manufacturer Received: 03/08/2018
• Initial Date FDA Received: 03/29/2018
• Supplement Dates Manufacturer Received: 03/08/2018; 05/04/2018
• Supplement Dates FDA Received: 04/04/2018; 05/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR