MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION SINGLE USE GUIDEWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/21/2023

Event Type  Injury  

Event Description

The user facility reported that during the endoscopic retrograde cholangiopancreatography (ercp) procedure, when a pr-v614m was removed, and a g-260-3545a remained in the bile duct, the tip of the guidewire broke about 10 cm.The broken tip remained in the guidewire lumen of the pr-v614m, which was replaced with another g-260-2545a and pr-v614m so that the procedure was continued.The patient had cholangiocarcinoma, and a bared metal stent had been placed in the bile duct, but due to tumor ingrowth into the metal stent, an additional plastic stent was placed inside it.To replace the plastic stent, contrast imaging was performed with pr-v614m, the guidewire was inserted, and the plastic stent was removed with a snare.The pr-v614m was then inserted again to perform contrast imaging, and when removing the pr-v614m, the surgeon noticed that the tip of the guidewire had fractured.The fractured piece remained at the tip of the pr-v614m.Another guidewire was placed in the contrast lumen, pr-v614m was carefully removed.The fractured guidewire tip was once dropped into the duodenum and then collected using biopsy forceps.The surgeon intentionally dropped the fragment into the body because the retrieval of the fragment was intended by pulling pr-v614 with the fragment remaining inside, there is a risk that the fragment will fall out unintentionally and unrecognized during this removal process, and its whereabouts may become unknown.For the purpose of secure retrieval, the surgeon chose to use grasping forceps.To grasp the fragment, the fragment was necessary to be visualized under the endoscope, so the surgeon dropped the fragment intentionally in the body.For the safety of the patient, the surgeon retrieved the fragment by the following procedure.The fragment once dropped in the duodenum was grasped at the proximal end with biopsy forceps and moved to the stomach, and then it was dropped intentionally.Next, the distal end of the fragment was grasped and retrieved from the patient.The procedure outcome was completed successfully.The patient's final impact was harmed but not seriously.The event occurred intra-operative.

Manufacturer Narrative

Udi: n/a as this product code is not exported to the us market.Implanted date: device was not implanted.Explanted date: device was not explanted.Investigation findings: code 19 is based upon the evaluation of the user facility information and investigation of the actual sample; code 4315 is based upon that close examination could not be performed.The actual device has been returned for evaluation.It was unknown whether the actual sample was contaminated by infectious agent or not, therefore the analysis was performed through the plastic bag.Visual inspection found that: (i) the actual sample was fractured into two portions.The distal and proximal portions were called "the fragment" and "the main body" respectively in this report; (ii) the total length of the fragment was approximately 250mm; (iii) the distal part of the main body (from the fracture end to approximately 8mm) had been curved.Review of the manufacturing record and the shipping inspection record of the involved product code/lot number found no anomaly in them.A search of the past complaint file regarding the involved product code/lot found no other similar cases reported from other facilities.Through the past simulation test, we have experienced that the guidewire was fractured when the following force was applied.In addition, we have been aware that there was regularity in the shape of the fracture section of core wire depending on the mechanism leading to the fracture.When torque force was applied clockwise and counterclockwise alternately, the side of fractured section of the core wire was in a flat shape, and a spiral pattern was found on the fracture surface.When 90° repeated bending force was applied, the side of fractured section of the core wire was in a diagonal shape, and a radial pattern was found on the fracture surface.From the investigation result, as a possible cause of this case, it was inferred that the actual sample was exposed to some excessive force (torquing or bending force) during ercp procedure, leading to the fracture.Since it was unknown whether the actual sample was contaminated by infectious agent, close examination could not be performed, and the cause of occurrence could not be clarified.Relevant instructions for use (ifu) reference: if any resistance is felt or if the tip's behavior and/or location seems improper, stop manipulating the guide wire and/or endo therapy accessory and determine the cause by fluoroscopy or endoscope.Continuing to manipulate the guidewire could cause patient injury, such as punctures, hemorrhages, or mucous membrane damage.It may also damage the endoscope, instrument and/or endo therapy accessory terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

• Brand Name: SINGLE USE GUIDEWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 16588344
• MDR Text Key: 311744556
• Report Number: 9681834-2023-00052
• Device Sequence Number: 1
• Product Code: OCY
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: OL-XA35455
• Device Lot Number: 28K(220811)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2023
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2022
• 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
• Treatment: OLYMPUS PR-V614M
• Patient Outcome(s): Other