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

Catalog Number OL-XA25455

Device Problem Difficult to Insert (1316)

Patient Problem Perforation (2001)

Event Date 05/13/2021

Event Type  Injury  

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.Expiration date - unknown due to unknown lot number.Udi - not required for product code.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.Device manufacturer date - unknown due to unknown lot number.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record and the product-release judgement record of the regarding potential lots (february-2021 ((b)(4)), march-2021((b)(4)), and april-2021((b)(4))) was conducted with no findings.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.It is likely that the perforation of the bile duct occurred when the guidewire was inserted into the bile duct and continued to be inserted under resistance.However, with no device return the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).

Event Description

The user facility reported that the single use guidewire was used in combination with a duodenoscope (tjf-260v) from olympus for papillary dilation.After that, an attempt was made to place the guidewire and insert an olympus biliary endoscope (chf-b290) into the bile duct; however, the insertion was not smooth and the guidewire was forcibly preceded in a direction that could not be determined to be into the bile duct.Then, the biliary endoscope was advanced tracking the guidewire.As a result, the bile duct was perforated.It is unknown whether the bile duct was perforated by the guidewire or by the biliary endoscope.The final patient impact was non-serious.The procedure outcome was not reported.

• Brand Name: SINGLE USE GUIDWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: mary o'neill ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12015215
• MDR Text Key: 262224336
• Report Number: 9681834-2021-00097
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2021

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: 05/21/2021
• Initial Date FDA Received: 06/17/2021
• 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