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

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2023

Event Type  malfunction  

Event Description

The user facility reported that the user attempted to preload a g-260-2545a with a competitor's (abis) mtw cannula while the involved product was being prepared prior to use.However, it could only be inserted halfway.Although the guidewire was replaced, the second one had the same problem.When it was replaced with a third one, the abis cannula was also replaced, and the insertion was completed.The procedure outcome was not reported.The final patient impact was not harmed.

Manufacturer Narrative

Actual samples upon receipt were, [sample 1] product code: ol-xa25355, lot no.: 220916, [sample 2] product code: ol-xa25355, lot no.: 221109, [competitor's product] mtw cannula, abis (product code and lot no.: unknown).Visual and magnifying inspections found the following: [sample 1] the distal end had been fractured.The outer layer had been abraded at approximately 1950mm - 1980mm.No anomaly such as a scratch or deformation was found in other sections.[sample 2] the distal end had been deformed.No anomaly such as a scratch or deformation was found in other sections.[competitor's product] the fractured piece of sample 1 had been remained in the lumen at approximately 2000mm from the hub.The fractured piece and the distal end of competitor's product were facing in the same direction, and the fractured piece was in a folded state.No damage that would cause sample 1 to fracture was found in other sections.Electron microscopic inspection in the vicinity of fractured section at the core wire of sample 1.Dimple patterns were found on the fracture surface (characteristics seen in the fracture surface fractured by external factors).Tapering was found on the fracture surface (characteristics seen in the fractured section fractured by pulling force).Bending was found in the vicinity of fractured section (characteristics seen in the vicinity of fractured section fractured with bent state).Confirmation of the dimensions (outer diameter of main body) of sample 1 and 2, they met the factory's specification.No anomaly was found.A simulation was performed.From investigation result 3, as a possible factor of fracture on sample 1, it was inferred that external pulling force was applied in a bent state (folded back or looped).Therefore, following simulation tests were performed.[simulation test a]: test method - repeated 90° bending force was applied while the distal end got stuck.Test result - dimple patterns were found on the fracture surface; no taper was found.[simulation test b]: test method - pulling force was applied in a looped state.Test result - tapering was found on the fractured section.Bending was found in the vicinity of fractured section.Dimple patterns were found on the fracture surface.Based on the above results, it was likely that since pulling force was applied in a looped state (folded state), sample 1 was fractured.Regarding "it could only be inserted halfway" described in the reported issue, since there was a reinforcement in the lumen of competitor's product, it was assumed that the resistance increased because our guidewire was entangled with the competitor's reinforcement.Therefore, following simulation test was performed between factory-retained products with the involved product codes.[simulation test c]: test method - when inserting our guidewire (visiglide) into a competitor's product, it was inserted while applying torque.Test result - since our guidewire was entangled with the competitor's reinforcement, the resistance increased, and it got stuck.However, it was not possible to simulate the looped state.The manufacturing record and the product inspection record of each sample found no anomaly.Past complaint file of each product with the involved product code/lot number, no other similar report was found.Based on the investigation result, the following mechanism was inferred.When inserting sample 1 into a competitor's product, it was inserted while applying torque force.Since sample 1 was entangled with the reinforcement inside the competitor's product, the resistance increased, and it got stuck.Then, since force was applied in the direction of insertion, the main body of sample 1 was in a looped state (folded state) and got stuck.Since pulling force was applied when sample 1 was removed from the competitor's product, sample 1 was fractured, and the fractured piece remained inside the competitor's product.After that, sample 2 was inserted.However, since the fractured piece of sample 1 got stuck inside the competitor's product, it could not be inserted, and the distal end was deformed.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 endotherapy 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 endotherapy 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: 16939594
• MDR Text Key: 315575988
• Report Number: 9681834-2023-00097
• 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: 05/16/2023

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: OL-XA25455
• Device Lot Number: 29K(220916)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2022
• 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: ABIS; MTW CANNULA