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

Model Number M00584040

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 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 coating of the preloaded guidewire was noted to be peeled and the hydrophilic tip detached exposing the tip of the metal corewire.The procedure was completed using 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 stable.

Manufacturer Narrative

A visual examination of the returned tome showed no anomalies or damages.The returned guidewire revealed that the polymer tip separated from the jacket at the dream end.The very tip of the corewire was not exposed.There is no evidence of fracture sections.The complaint is not consistent with the returned guidewire since the very tip of the corewire was not exposed.It is possible that the way in which the device was handled and manipulated during unpacking may have contributed to the failure reported.Therefore, the most probable root cause is handling damage.A dhr (device history record) review was performed and no deviation was found.

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 coating of the preloaded guidewire was noted to be peeled and the hydrophilic tip detached exposing the tip of the metal corewire.The procedure was completed using 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 stable.

• 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: 5736110
• MDR Text Key: 47751203
• Report Number: 3005099803-2016-01699
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K013153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2019
• Device Model Number: M00584040
• Device Catalogue Number: 8404
• Device Lot Number: 19000982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2016
• 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