MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX URINARY DIVERSION STENT; CATHETER, NEPHROSTOMY

Model Number	M0061603300
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Problem code captures the reportable event of  stent migration. 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 medwatch will be filed.
Event or Problem Description
Sit was reported to boston scientific corporation that a percuflex stent was implanted in a patient on an unknown date.According to the complainant, the patient came back to the hospital for reasons unknown and it was discovered that the stent had migrated it was reported that the stent may have migrated due to the stent length being incorrect.A second percuflex stent was then implanted in the patient.There was no serious injury nor were there any adverse patient effects reported as a result of this event.The patient was reported to in stable condition post procedure.
Additional Manufacturer Narrative
Problem code 4003 captures the reportable event of stent migration.Investigation results: a urinary diversion stent was returned for analysis.A visual evaluation of the returned device revealed that it was returned with the catheter connector.The red connector was disassembled and the grommet was noticed to be missing.It was not returned with the device.No other defects were noted.A functional evaluation was performed and the urinary diversion stent was introduced inside the connector (red) and the stent passed properly.The connector was screwed to the stent and failed the functional test due to the missing grommet; consequently confirming the event of the stent being disconnected and migrating.Based on event analysis, it is most likely that during unpacking, preparation or during the procedure, when the red connector was disassembled, the grommet became lost.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.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.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex stent was implanted in a patient on an unknown date.According to the complainant, the patient came back to the hospital for reasons unknown and it was discovered that the stent had migrated.It was reported that the stent may have migrated due to the stent length being incorrect.A second percuflex stent was then implanted in the patient.There was no serious injury nor were there any adverse patient effects reported as a result of this event.The patient was reported to in stable condition post procedure.

• Brand Name: PERCUFLEX URINARY DIVERSION STENT
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8039410
• Report Number: 3005099803-2018-61208
• Device Sequence Number: 1187801
• Product Code: LJE
• UDI-Device Identifier: 08714729821144
• UDI-Public: 08714729821144
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K830803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2019

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: 02/25/2021
• Device Model Number: M0061603300
• Device Catalogue Number: 160-330
• Device Lot Number: 0022603360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 01/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention