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

Catalog Number OL-XA25455

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

Patient Problems Pain (1994); Tingling (2171); Twitching (2172); Discomfort (2330)

Event Date 01/03/2019

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.Date of event: requested, not provided.Lot number: subjected lots: 180913, 180922, 180925,180926, 181010, 181013, 181024, and 181025, which were manufactured in september 2018 - october 2018.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.Device manufacture date - unknown due to unknown lot number.Name and address- requested, not provided.Phone number- requested, not provided.Health professional- requested, not provided.Occupation- requested, not provided.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 product release decision control sheets of the product code/lot#' (manufactured in september 2018 - october 2018) combinations were conducted with no findings.Review of the biological safety tests results for the past three years did not find any deviation or nonconformity in the records.In the product design stage, this product was verified to meet the biological safety criteria (cytotoxicity test, skin sensitization test, intradermal reaction test, acute toxic reaction, pyrogenic substance test, and haemolysis test) in accordance with iso10933.Ashitaka factory performs the following safety tests regularly: sterilization test (iso11135): per sterilization batch; endotoxin test ((b)(4) standard): per production lot; extraction test (approval standard for disposable device sets for artificial heart-lung machine): once every six months; and eto residual (eo and ech) test (iso10993-7): once every four months.With no return of the actual device, 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 they have noticed an issue with the patient experiencing what seems to be pain, muscle spasms/twitching or discomfort during sphincterotomy.Ercp potential visiglide guidewire concern.They have had their diathermy tested by ebme (reported fine) and they have apparently noticed that if they retract the guidewire almost; however, not quite fully into the sphincterotome when any pain/spasm type symptoms occur with the patient that these issues no longer occur.They feel through the process of elimination the guidewire is the potential issue/common factor.The procedure was completed on (b)(6) 2019.The endoscopist described it to be "distressing electric shocks" which were felt by the nurse as well.The accessory used: olympus guide wire -visi guide.The patient felt twitching/pulsation, muscle cramps, tingling, discomfort, etc., which appeared to be painful.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: theresa mussaw ; reg. no. 2243441; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 9626787
• MDR Text Key: 190042889
• Report Number: 9681834-2019-00242
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/24/2020

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: 12/27/2019
• Initial Date FDA Received: 01/24/2020
• 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