FDA.reportPublic FDA data

MAUDE MDR 7381660

MDR report key
7381660
Report number
3005099803-2018-00943
Event key
0
Event type
3
Date of event
2018-01-10
Date received
2018-03-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
EMP. NANCY CUTINO
Address
100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US
Phone
508-508-5086
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1STONE CONE NITINOL UROLOGICAL RETRIEVAL COILDISLODGER, STONE, FLEXIBLEBOSTON SCIENTIFIC - MARLBOROUGHFGOM0063903100390-3100003768067Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-03-2901. H; 2. R

Event Narratives#

N

Patient 1

(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.

D

Patient 1

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.