MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) DREAMTOME? RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00584040

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a dreamtome¿ rx 44 was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure.According to the complainant, during preparation, the preloaded guidewire would not advance out of the tip of the tome.It was noted that a "small piece of metal" was blocking the guidewire lumen.Reportedly, there was no visible damage noted on the dreamtome¿ rx 44 including the preloaded guidewire.The procedure was completed with a second dreamtome¿ rx 44.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 with no known patient complications.This event has been deemed reportable based on the investigation results: the evaluation of the device revealed an additional portion of cutting wire.

Manufacturer Narrative

Visual examination of the dreamtome device found the working length to be twisted.The cutting wire on the device was intact; however, the device was found with an additional portion of cutting wire.The guidewire was inspected, and no anomalies or damages were noted.Moreover, the notch was inspected and no anomalies or damages were noted.The wire which was received loaded in the tome was withdrawn without resistance, and then was loaded and no resistance was met.Based on the product analysis, although the cutting wire of the device was intact, it was found that the returned unit has an additional portion of cutting wire.Therefore, the most probable root cause is manufacturing and there is an investigation in place to address this issue a search of the complaint database revealed that no similar complaints exist for the specified lot.The device history record (dhr) was performed; no anomalies were noted.

• Brand Name: DREAMTOME? RX 44
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4784429
• MDR Text Key: 5801069
• Report Number: 3005099803-2015-01376
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/01/2017
• Device Model Number: M00584040
• Device Catalogue Number: 8404
• Device Lot Number: 17084575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2014
• 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