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

Model Number M0061453520

Device Problems Unsealed Device Packaging (1444); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific that during unpacking, it was noticed that the packaging of a percuflex ureteral stent was damaged and was not completely sealed.The sterility of the device was reported to be compromised.Another percuflex ureteral stent was opened and used and successfully completed the procedure.A photo of the complaint device was provided and showed that the stent was torn.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.

Manufacturer Narrative

Block a2: patient's exact age is unknown; however, it was reported that the patient was under the age of 18.Block e1: initial reporter facility name: (b)(6) hospital.Block h6: imdrf device code a020503 captures the reportable event of unsealed device packaging.

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was under the age of 18.Initial reporter facility name: hu bei wu han city integrated traditional & western medical hospital imdrf device code a020503 captures the reportable event of unsealed device packaging.The returned percuflex ureteral stent was analyzed, and a visual evaluation noted that the device suture hole was torn and the suture was not visible.The suture, positioner and the pouch were not returned.A photo of the device was provided, and it was also observed that the suture hole was torn.A functional evaluation noted that a mandrel of 0.036" and passed through the stent without resistance.No other issues were noted.The reported event of packaging seal compromised was not confirmed, however, the stent torn material was confirmed.Based on all the gathered information and the analysis of the returned device, it is possible to conclude that the cause was due to an interaction of the device with the suture string such as entanglement, manipulation or excess of force applied during the preparation, this has caused the torn that was observed, affecting the performance of the device.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.

Event Description

It was reported to boston scientific that during unpacking, it was noticed that the packaging of a percuflex ureteral stent was damaged and was not completely sealed.The sterility of the device was reported to be compromised.A photo of the complaint device was provided and showed that the stent was torn.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.

• Brand Name: PERCUFLEX
• Type of Device: 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: 16791674
• MDR Text Key: 313779292
• Report Number: 3005099803-2023-02034
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729040279
• UDI-Public: 08714729040279
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K834468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

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
• Device Operator: Health Professional
• Device Model Number: M0061453520
• Device Catalogue Number: 145-352
• Device Lot Number: 0029264743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 04/21/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1