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

Catalog Number OL-XA25455

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

Patient Problem Perforation (2001)

Event Type  Injury  

Event Description

An article titled "study of endoscopic trans-papillary gallbladder drainage for acute cholecystitis - technical tips for difficult cases of cystic duct intubation (translation from original japanese title) ", it was found that a perforation of the cystic duct was reported as an accidental adverse event.Although visiglide was not listed in the literature as a device used, the following additional information was obtained during an interview with dr.(b)(6) of (b)(6) hospital, the author of the literature, and it was found that ol-xa25455 was also involved in the incident.The incident occurred in a procedure in 2016.The cystic duct was extremely bent in the foot direction (papillary direction).Therefore, after the common bile duct was contrasted with a swing tip, while the swing tip was being aimed at the cystic duct, the visiglide (the guidewire) was exited from the distal end of the swingtip to perform seeking.Upon confirmation of the guidewire having been advanced toward the direction of the mouth side of cystic duct, the swingtip was inserted to the cystic duct for contrast imaging, however, no image of cystic duct was obtained.Based on the fluoroscopic image, it was confirmed that, at the aperture of cystic duct, the guidewire remained in the direction of mouth-side.From this, it was inferred that the perforation had occurred.It was concluded with a presumption that the perforation occurred at the aperture of cystic duct in the mouth-side direction when seeking was being performed with the guidewire.The procedure outcome was not reported.The patient was harmed however not serious.

Manufacturer Narrative

Patient identifier - requested, not provided, age & date of birth - requested, not provided, patient sex - requested, not provided, weight - requested, not provided , ethnicity - requested, not provided, race - requested, not provided, lot number - requested, not provided, unknown due to unknown lot number, 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, name - requested, not provided, health professional- requested, not provided, occupation- requested, not provided, manufacture date - unknown due to unknown lot number.The actual sample was discarded by the involved facility.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Review of manufacturing records or product-release judgement records could not be performed since the involved lot number was unknown.Regarding the involved product code (ol-xa25455), the complaint records of the last five years (april 2017 - april 2022) were reviewed and four similar report from another facilities were found.In all four cases, the actual samples were not available, and in three of them, the involved lot numbers were unknown.As for the remaining one case, no anomaly was found in the manufacturing record and product-release judgement record, therefore, it was concluded that there was no problem with the product.In the manufacturing record of the last five years (april 2017 - april 2022), any nonconformity or deviation that could relate to perforation issues was not recorded.Based on the results of the investigation and the description of the event, as one of the possibilities in this case, it was presumed that the perforation occurred when the tip of the guidewire might have unexpectedly come into contact with the aperture of the cystic duct.It was presumed that it occurred during the seeking process with the tip of the actual product exited from the distal end of the swing tip.Ifu states: "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." (b)(4).

• Brand Name: SINGLE USE GUIDWIRE
• 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: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 14332480
• MDR Text Key: 293108350
• Report Number: 9681834-2022-00085
• 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: 05/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: OL-XA25455
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 05/08/2022
• 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
• Treatment: STARTIPV - OLYMPUS; SWING TIP - OLYMPUS
• Patient Outcome(s): Other