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 Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

Reported event of guidewire distal tip detached exposing the tip of the metal corewire.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 in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2015.According to the complainant, during the procedure, the stent was loaded onto the dreamwire guidewire that was already in place, as they were deploying the stent, the physician experienced difficulty removing the dreamwire guidewire from the delivery catheter.When the physician pulled the guidewire back, it was noticed that the hydrophilic coating got detached inside the patient, exposing the tip of the metal corewire.The guidewire and delivery catheter for the stent were removed and the detached portion of the hydrophilic coating of the guidewire was successfully retrieved using a captiflex snare.The procedure was completed using this device.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 fine.

Manufacturer Narrative

Visual analysis of the tome device has the working length twisted.The guidewire returned has the jacket peeled exposing the corewire in the middle section.The core wire was intact and the distal tip (polymer tip) was detached exposing the corewire end.The complaint is consistent with the returned guidewire since the distal tip got detached, exposing the corewire tip.It is most likely that the failures found could have been generated during the procedure due to clinical or procedure factors.Therefore, the most probable root cause is "operational context¿, since it is most likely that due to anatomical and/or procedural factors encountered during the procedure, performance was limited.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 in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2015.According to the complainant, during the procedure, the stent was loaded onto the dreamwire guidewire that was already in place, as they were deploying the stent, the physician experienced difficulty removing the dreamwire guidewire from the delivery catheter.When the physician pulled the guidewire back, it was noticed that the hydrophilic coating got detached inside the patient, exposing the tip of the metal corewire.The guidewire and delivery catheter for the stent were removed and the detached portion of the hydrophilic coating of the guidewire was successfully retrieved using a captiflex snare.The procedure was completed using this device.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 fine.

• 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: 5298974
• MDR Text Key: 33551725
• Report Number: 3005099803-2015-03606
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/03/2018
• Device Model Number: M00584040
• Device Catalogue Number: 8404
• Device Lot Number: 18347999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2015
• 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
• Patient Age: 42 YR