MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA SINGLE USE GUIDEWIRE; WIRE, GUIDE, CATHETER

Catalog Number OL-XA25455

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Internal Organ Perforation (1987)

Event Date 03/07/2016

Event Type  Injury  

Manufacturer Narrative

The actual device was discarded by the involved facility and the lot number was not provided.Therefore the investigation is based upon the user facility information and the evaluation of current product.Visual inspection found no anomalies in the appearance which would have related to the reported issue.Magnifying inspection confirmed there were no anomalies on the outer surface and it was confirmed that the distal tip processing had been performed properly.The outside diameter was confirmed to meet manufacturing specifications.The mobility performance on the segment at the distal end where the hydrophilic coating is applied, was confirmed to be normal and no deterioration in the lubricity of the device was noted.The pushing resistance was determined when the distal end of the current product sample was pushed against a silicone rubber, the obtained values were verified to be comparable to those of the previous product sample.The production lot number was not provided by the user facility, which prevented a meaningful review of production and complaint records.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause cannot be determined based on the available information the current product sample was confirmed to be normal product.The ifu of this product does have the statement in the warnings section."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 potion 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 mucus membrane damage.It may also damage the endoscope, instrument and/or endo therapy accessory." (b)(4).All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.Actual device was discarded.

Event Description

The user facility reported organ perforation in a patient while using a guidewire device.Follow up communication with the user facility reported the following information; the actual device was used to cross the stenosed segment; using the deep cannulation, angiography found that the central bile duct had been perforated; pr-v234q and the actual device were removed; another root in the bile duct was searched; immediately after the procedure, ct imaging found that the bile duct and the intestinal tract had also been perforated; the procedure was completed successfully; and it was reported that the patient recovered.

• Brand Name: SINGLE USE GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 5549839
• MDR Text Key: 41956015
• Report Number: 9681834-2016-00074
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: OL-XA25455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2016
• 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; Required Intervention
• Patient Age: 82 YR