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

Catalog Number OL-XS25453M

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

Patient Problem Pain (1994)

Event Date 01/06/2020

Event Type  Injury  

Manufacturer Narrative

Lot number: subjected lots: 191001, 191003, 191018, 191022, and 191023, which were manufactured in october 2019.Expiration date - unknown due to unknown lot number; estimated date: 30sep2022.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.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/ subjected lot#'s combinations were conducted with no findings.Review of the test results for the past three years found no anomaly in the records.Sterilization test (iso11135): per sterilization batch; endotoxin test(jp standard ): per production lot; extraction test (approval standard for disposable device sets for artificial heart-lung machine): once every six months; eto residual (eo and ech) test (iso10993-7): once every four months.In the product design stage, this product has been verified to meet the biological safety criteria in accordance with iso10933 (cytotoxicity test, skin sensitization test, intradermal reaction test, acute toxic reaction, pyrogenic substance test, and haemolysis test).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 the involved single use guidewire was used during the procedure.The doctor was performing an ercp procedure with an icc 200 erbe machine, visiglide guidewire and a diagmed sphincterotome.The bile duct was cannulated using the sphincterotome and a visiglide wire was inserted into the duct.Contrast was injected, and x-rays were used to ensure the wire was in the bile duct.The sphincterotome was bowed while the wire was still in the duct, and diathermy was used to perform a sphincterotomy.Immediately after the diathermy started to cut the ampula, the patient jolted, and the doctor stopped using the diathermy.The visiglide was then removed from the sphincterotome and a boston jagwire was used and inserted up into the duct.The doctor then continued to use diathermy to continue the sphincterotomy with no issues.The procedure was completed as normal and the patient did not appear to be in any pain after.The erbe was set to default settings of 150 cut 30 coag effect 2.The procedure was completed successfully.

• 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: 9659594
• MDR Text Key: 190430678
• Report Number: 9681834-2020-00006
• 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: 02/03/2020

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-XS25453M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 02/03/2020
• 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