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

Model Number	M006175253080
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a procedure, performed on (b)(6) 2022.During preparation, when the physician attempted to insert the stent into the patient, it could not be inserted due to there was no stiffness at the tip.Another perculfex plus ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).(b)(4).The returned percuflex plus ureteral stent was analyzed, and a visual evaluation noted that the bladder pig tail was buckled accordion.The suture and positioner was not returned.Both coils look in good condition and they still having their original shape.During the functional analysis, a use of a mandrel of 0,036" passed through the stent without resistance.Proceeded to perform a dimensional test which passed successfully in a measurement of stent length ("l-1") with 26cm.Finally, during magnification it was observed closely that it was buckled accordion on the bladder pig tail and it was observed there were several drag marks in the bladder pig tail.Also was possible observed that several side port holes are stretch out in both pig tails.No other issues noted to the device.The reported event was not confirmed.According to the product analysis, it was found that a bladder pig tail was buckled accordion and observed that side port holes of both pig tails (bladder and renal) were stretched out.Regarding with found issues, bladder pig tail buckled accordion and side port holes stretch out is possible that happened during the interaction with the positioner/pusher, excess of force applied to the stent such as operational factors during it use in the preparation, it could have caused the found issues.Consequently, affect the performance of the device.Therefore, 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.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a procedure, performed on (b)(6) 2022.During preparation, when the physician attempted to insert the stent into the patient, it could not be inserted due to there was no stiffness at the tip.Another perculfex plus ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter address 1: chuo-ku kita-nagasa-dori 5-7-17 block h6: medical device problem code a040601 captures the reportable investigation result of stent buckled material.Block h10: the returned percuflex plus ureteral stent was analyzed, and a visual evaluation noted that the bladder pig tail was buckled accordion.The suture and positioner was not returned.Both coils look in good condition and they still having their original shape.During the functional analysis, a use of a mandrel passed through the stent without resistance.Proceeded to perform a dimensional test which passed successfully in a measurement of stent length ("l-1") with 26cm.Finally, during magnification it was observed closely that it was buckled accordion on the bladder pig tail and it was observed there were several drag marks in the bladder pig tail.Also, it was possible to observe that several side port holes were stretched out in both pig tails.No other issues noted to the device.The reported event of coil memory was not confirmed.According to the product analysis, it was found that a bladder pig tail was buckled accordion and observed that side port holes of both pig tails (bladder and renal) were stretched out.Regarding with found issues, bladder pig tail buckled accordion and side port holes stretch out is possible that happened during the interaction with the positioner/pusher, excess of force applied to the stent such as operational factors during it use in the preparation, it could have caused the found issues.Consequently, affect the performance of the device.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.Block h11: correction to block h6: device codes.

• Brand Name: PERCUFLEX PLUS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15199807
• Report Number: 3005099803-2022-04393
• Device Sequence Number: 20393774
• Product Code: FAD
• UDI-Device Identifier: 08714729297338
• UDI-Public: 08714729297338
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

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: 12/08/2024
• Device Model Number: M006175253080
• Device Catalogue Number: 175-253-08
• Device Lot Number: 0028892398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown