MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX PLUS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M006175253050
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Migration (4003)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(6).(b)(4).According to the complainant, the suspect device has been contaminated and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a ureteral stent placement procedure between in the kidney and bladder performed on (b)(6) 2020.According to the complainant, during the procedure, after the physician successfully implanted the ureteral stent, the position was checked through flouroscopy.It was noticed in the x-ray that the stent moved due to one of the pigtails was stretched.The physician attempted to move the stent back to the appropriate position, but the pigtail was stretched and failed to return to its circular shape, it curled.The stent was removed from the patient and a non-bsc ureteral stent successfully completed the procedure.Photos of the complaint device were provided by the complainant after the procedure and showed the coil detached.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 and fine.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a ureteral stent placement procedure between in the kidney and bladder performed on (b)(6) 2020.According to the complainant, during the procedure, after the physician successfully implanted the ureteral stent, the position was checked through flouroscopy.It was noticed in the x-ray that the stent moved due to one of the pigtails was stretched.The physician attempted to move the stent back to the appropriate position, but the pigtail was stretched and failed to return to its circular shape, it curled.The stent was removed from the patient and a non-bsc ureteral stent successfully completed the procedure.Photos of the complaint device were provided by the complainant after the procedure and showed the coil detached.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 and fine.Additional information received on november 19, 2020.The stent was removed from the patient through the rigid ureteroscope and a non-bsc ureteral stent successfully completed the procedure.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block e1: initial reporter state: (b)(6).Block h6: device code 4003 captures the reportable event of stent migration.Device code 2907 captures the reportable event of stent coil detached inside the patient.Block h10: according to the complainant, the suspect device has been contaminated and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.Additional information: block b5 has been updated based on additional information received on november 19, 2020.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block e1: initial reporter state: 15 block h6: medical device problem code a010402 captures the reportable event of stent migration.Medical device problem code a0501 captures the reportable event of stent coil detached inside the patient.No other issues with the device were noted.Block h10: the returned percuflex plus ureteral stent was analyzed, and a visual evaluation noted that the renal pigtail tip was detached.The suture string and the renal pigtail section detached was not retuned with the device.Additionally, a review of the picture sent by the complainant reveals a detachment of the pigtail section.No other problems with the device were noted.The reported event of coil detachment of device or device component was confirmed.The coil of the stent was detached.The device was outside the original pouch and without the suture string loaded in the device, evidence that the stent was manipulated.The failure found is a problem that could have been generated by the user or due to the interacting of the device with the suture string or other devices involved during procedure.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint since it is the most likely that the adverse event occurred during the procedure and the device had no influence on event.Additionally, the device migration reported by the costumer and based on the information available, the most probable cause of this failure is known inherent risk of device since reported adverse event known and documented in the labeling.The device was observed with the bladder pigtail detached and this condition affected the correct device functionality.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a ureteral stent placement procedure between in the kidney and bladder performed on (b)(6) 2020.According to the complainant, during the procedure, after the physician successfully implanted the ureteral stent, the position was checked through fluoroscopy.It was noticed in the x-ray that the stent moved due to one of the pigtails was stretched.The physician attempted to move the stent back to the appropriate position, but the pigtail was stretched and failed to return to its circular shape, it curled.The stent was removed from the patient and a non-bsc ureteral stent successfully completed the procedure.Photos of the complaint device were provided by the complainant after the procedure and showed the coil detached.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 and fine.The stent was removed from the patient through the rigid ureteroscope and a non-bsc ureteral stent successfully completed the procedure.

• Brand Name: PERCUFLEX PLUS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10848970
• Report Number: 3005099803-2020-05287
• Device Sequence Number: 3211301
• Product Code: FAD
• UDI-Device Identifier: 08714729339977
• UDI-Public: 08714729339977
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2023
• Device Model Number: M006175253050
• Device Catalogue Number: 175-253-05
• Device Lot Number: 0025393793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 10/21/2020; 04/15/2021
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 11/19/2020; 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1