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

Model Number	M006175253050
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that a percuflex plus ureteral stent was used during a stent placement procedure in the kidney for kidney stoned performed on (b)(6) 2021.During preparation, when trying to remove the suture; the stent was torn and the coil was detached.Additionally, the stent shaft was broken into two pieces.The procedure was successfully completed with another percuflex plus ureteral stent.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 good.
Event or Problem Description
It was reported that a percuflex plus ureteral stent was used during a stent placement procedure in the kidney for kidney stoned performed on (b)(6) 2021.During preparation, when trying to remove the suture; the stent was torn and the coil was detached.Additionally, the stent shaft was broken into two pieces.The procedure was successfully completed with another percuflex plus ureteral stent.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 good.
Event or Problem Description
It was reported, that a percuflex plus ureteral stent was used, during a stent placement procedure in the kidney.For kidney stoned performed on (b)(6) 2021.During preparation, when trying to remove the suture.The stent was torn and the coil was detached.Additionally, the stent shaft was broken into two pieces.The procedure was successfully completed with another percuflex plus ureteral stent.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 good.
Additional Manufacturer Narrative
Block h6: medical device code a0401, captures the reportable event of stent broken.Block h10: the returned percuflex plus ureteral stent was analyzed.And a visual evaluation noted, that the bladder pigtail section was detached.The detached section was buckled/accordion.Additionally, the suture hole was torn and the tip had a drag mark.The suture string was not returned.No other problems with the device were noted.The reported event of stent shaft break was not confirmed, but the reported event of coil detached was confirmed.The analysis of the returned ureteral stent revealed, that the bladder coil was detached.Also, the detached bladder pigtail was buckled/accordion.This problem could have been generated, due to the force used when the stent was pushed up with the pusher/positioner over the guidewire or when the stent was used.Additionally, the suture string was not returned.And the suture hole torn and buckled/accordion, evidence that the device was manipulated.It is most likely, that the problem was generated, due to the manipulation/handling of the device or due to the interaction with other devices, during the procedure.A functional evaluation noted, that there was no resistance upon loading a mandrel into the device.And the guidewire was unloaded without problems.The investigation concluded, that adverse event related to procedure is selected as the most probable root cause for the complaint.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 instructions for use (ifu) product label.Block h11: correction to field h6 (device code) upon review of the complaint.
Additional Manufacturer Narrative
Block h6: medical device code a0401 captures the reportable event of stent broken.Block h10: the returned percuflex plus ureteral stent was analyzed, and a visual evaluation noted that the bladder pigtail section was detached.The detached section was buckled/accordion.Additionally, the suture hole was torn and the tip had a drag mark.The suture string was not returned.No other problems with the device were noted.The reported event of stent shaft break was not confirmed, but the reported event of coil detached was confirmed.The analysis of the returned ureteral stent revealed that the bladder coil was detached; also, the detached bladder pigtail was buckled/accordion.This problem could have been generated due to the force used when the stent was pushed up with the pusher/positioner over the guidewire or when the stent was used.Additionally, the suture string was not returned and the suture hole torn and buckled/accordion, evidence that the device was manipulated.It is most likely that the problem was generated due to the manipulation/handling of the device or due to the interaction with other devices during the procedure.A functional evaluation noted that there was no resistance upon loading a mandrel into the device and the guidewire was unloaded without problems.The investigation concluded that adverse event related to procedure is selected as the most probable root cause for the complaint.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 instructions for use (ifu) / product label.Block h11: correction to field h6 (device code) upon review of the complaint.

• 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: 11657812
• Report Number: 3005099803-2021-01659
• Device Sequence Number: 4224548
• Product Code: FAD
• UDI-Device Identifier: 08714729339977
• UDI-Public: 08714729339977
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 05/13/2021

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: 08/27/2023
• Device Model Number: M006175253050
• Device Catalogue Number: 175-253-05
• Device Lot Number: 0026344620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 04/22/2021; 05/11/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/11/2021; 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1