MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRIA FIRM; STENT, URETERAL

Model Number M006190223090

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 02/16/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported that a tria firm ureteral stent was used during an transurethral lithotripsy procedure in the lower urinary tract performed on (b)(6) 2022.During procedure, it was reported that a "hair like" foreign material was found inside the sterile packaging of the tria firm ureteral stent.No damage has been found in the tria firm ureteral stent.The procedure was successfully completed with another tria firm 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 as no patient injury.

Manufacturer Narrative

Block h6: medical device code a1802 captures the reportable event of packaging foreign matter.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported that a tria firm ureteral stent was used during an transurethral lithotripsy procedure in the lower urinary tract performed on february 16, 2022.During the procedure, it was reported that a "hair like" foreign material was found inside the sterile packaging of the tria firm ureteral stent.No damage has been found in the tria firm ureteral stent.The procedure was successfully completed with another tria firm 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 as no patient injury.Additional information received that the tria firm ureteral stent was used inside the patient and the lot number and device photo could not be obtained.

• Brand Name: TRIA FIRM
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13766412
• MDR Text Key: 288826960
• Report Number: 3005099803-2022-01164
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 04/07/2022

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
• Device Operator: Health Professional
• Device Model Number: M006190223090
• Device Catalogue Number: 1983-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 03/15/2022
• Supplement Dates FDA Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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