MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) STRETCH¿ VL; TUBE, DRAINAGE, SUPRAPUBIC

Model Number	M006185155180
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event of "stent detached".Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 to boston scientific corporation that a stretch¿ vl ureteral stent was used in the ureter during a stent placement procedure performed on (b)(6) 2017.According to the complainant, after the stent was placed, forceps were used to adjust the position by pulling on the stent.However, the stent coil detached from the stent while inside the patient.Forceps were then used to remove the detached piece of stretch¿ vl ureteral stent from the patient.The procedure was completed with another stretch¿ vl ureteral stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
A visual evaluation found that the returned stretch vl stent was damaged in one of its sides and the pigtail was detached.Investigation confirmed that the stent was damaged in one of its sides and the pigtail was detached.Based on all available information, the complaint is due to a known physiological effects of the procedure noted within the directions for use.Therefore, the most probable root cause is "anticipated procedural complication".A review of the device history record (dhr) confirms that the accepted device met all manufacturing specifications.A search of the complaint database confirmed that no similar complaints exist for the specified batch.A labeling review was performed and no anomaly was found.
Event or Problem Description
It was reported to boston scientific corporation that a stretch¿ vl ureteral stent was used in the ureter during a stent placement procedure performed on (b)(6) 2017.According to the complainant, after the stent was placed, forceps were used to adjust the position by pulling on the stent.However, the stent coil detached from the stent while inside the patient.Forceps were then used to remove the detached piece of stretch¿ vl ureteral stent from the patient.The procedure was completed with another stretch¿ vl ureteral stent.There were no patient complications reported as a result of this event.

• Brand Name: STRETCH¿ VL
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6546632
• Report Number: 3005099803-2017-01357
• Device Sequence Number: 18850607
• Product Code: FFA
• UDI-Device Identifier: 08714729777250
• UDI-Public: (01)08714729777250(17)20191031(10)0020178586
• Combination Product (Y/N): N
• PMA/510(K) Number: K944290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: M006185155180
• Device Catalogue Number: 185-155-18
• Device Lot Number: 0020178586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2017
• Supplement Report FDA Received Date: 05/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention