MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA VISIGLIDE GUIDEWIRE

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Internal Organ Perforation (1987)

Event Date 06/11/2014

Event Type  Injury  

Event Description

The user facility reported that a visiglide guidewire was used to perform an endoscopic retrograde cholangiopancreatography (ercp) procedure.However, when the guidewire was inserted through the papilla, the diverticulum was perforated.The originally planned ercp was then switched to an endoscopic ultrasonography - bile duct drainage (eus-bd) procedure.No additional information has been provided by the user facility.

Manufacturer Narrative

Other - based on user facility information, the patient suffered a perforated organ as a result of this event.This section was completed by the manufacturer per cfr 803.52(f) (11) because the information was not initially completed by the user facility.The actual device was not returned for evaluation and only partial lot number information was provided by the user facility.Therefore, the retention samples in the identified group (43k) were evaluated ((b)(4)).Examination and testing confirmed there were no defects or anomalies and that product performance specifications were met.A review of the device history record of the reserve samples indicated that there were no production related problems for these lot numbers.A review of the complaint files of the reserve samples confirmed that these lot numbers have not been reported previously.Visual inspection confirmed there were no defects or anomalies.Although the cause of the reported event cannot be definitively determined based upon the available information, there is no evidence that the reported event was related to a preexisting device defect or malfunction.The device labeling does address the potential for such an event with statements in the warnings / precautions section of the instructions-for-use that state: "do not insert the instrument into the endoscope or endo therapy accessory unless movements of the instrument can be observed under clear endoscopic or x-ray image.If you cannot see the distal end of the insertion portion in the endoscopic or x-ray image, do not use the instrument.Otherwise unintended movements of the instrument could cause patient injury, such as punctures, hemorrhages or mucous membrane damage.It may also damage the endoscope, instrument and/or endo therapy accessory." all available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.(b)(4).Device not returned to manufacturer.

• Brand Name: VISIGLIDE GUIDEWIRE
• Type of Device: GUIDEWIRE
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: cathleen hargreaves ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 3959723
• MDR Text Key: 21721336
• Report Number: 9681834-2014-00211
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2014,07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: N/A
• Device Catalogue Number: OL-XA25455
• Device Lot Number: 43K
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/11/2014
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2014
• Date Manufacturer Received: 07/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other