MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER TRUETOME? 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00584170

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2015

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a truetome¿ 44 was used in the duodenum and biliary during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2015.According to the complainant, during the procedure, they noticed that the truetome¿ 44 has split with ¿cotton material.¿ reportedly, the device was not tested prior to use and there was no visible damage noted to the device.The procedure was completed with a second truetome¿ 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

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.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.

Manufacturer Narrative

No failure detected; the device evaluation found no evidence of a foreign matter in the device, however, the exposed cutting wire and extrusion in the same area were kinked/ bent.A resistance was also noted when advancing the guidewire into the guidewire luer and out the tip.A visual examination of the returned device found that the tip has no issue and has been properly formed during the manufacturing process.There was no foreign material found on the tip area.The exposed cutting wire and extrusion in the same area was kinked/ bent.A functional evaluation was performed by inserting a.035" jagwire into the guidewire luer and out the tip with resistance noted in the kinked/ bent area.Additionally, no foreign material was found inside the guidewire lumen.The device evaluation found that the tip has no damage and no foreign material was found inside the device, therefore, the most probable root cause is not confirmed.A search of the complaint database revealed that no similar complaints exist for the specified lot.The device history record review found the device met all manufacturing specifications.

Event Description

It was reported to boston scientific corporation that a truetome 44 was used in the duodenum and biliary during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2015.According to the complainant, during the procedure, they noticed that the truetome 44 has split with "cotton material".Reportedly, the device was not tested prior to use and there was no visible damage noted to the device.The procedure was completed with a second truetome 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: TRUETOME? 44
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4579029
• MDR Text Key: 5486333
• Report Number: 3005099803-2015-00570
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K122203
• 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: Initial,Followup
• Report Date: 02/17/2015

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: Physician
• Device Expiration Date: 10/31/2016
• Device Model Number: M00584170
• Device Catalogue Number: 8417
• Device Lot Number: 17386978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2015
• Initial Date FDA Received: 03/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2014
• 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