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

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

An adverse event of acute pancreatitis was reported in a literature entitled "case report transjejunal endoscopic ultrasound-guided pancreatic drainage for pancreatic jejunostomy stricture using a forward-viewing echoendoscope in a patient with altered anatomy." (den open 10.1002 / deo2.114).Although the involved product was described in the literature, the product name could not be specified, and the above model was selected as the representative model.No relevance between the reported adverse event and the involved device has been reported in the literature, nor has any failure of the device itself been reported.The procedure outcome was not reported.The patient had minor harm however, did not have serious injury.

Manufacturer Narrative

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.Establishment name - (b)(6).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.Since the lot number was unknown, the manufacturing record and the shipping inspection record could not be reviewed.A search of the complaint file in the past 5 years (may 2017 to may 2022) found four similar reports with the involved product code (ol - xa25455).As a result of confirming the details, it was found that each case was reported from the published literature.The first case was a case where acute pancreatitis and infectious disease after ercp were reported, the second case was a case where an accidental symptom after eus-hgs was reported, the third case was a case in which acute cholecystitis after sems placement was reported, and the fourth case was a case in which bleeding due to eus guided drainage was reported.Therefore, each occurrence situation was different from this case.In addition, since each actual product was not returned and each lot number was unknown for four cases, the causal relationship between the involved product and the involved case was unknown.At the product design stage, the involved product has been confirmed for biological safety evaluation (cytotoxicity test, skin sensitization test, intradermal test, acute toxicity reaction, pyrogen test, hemolysis test) based on iso10993.Ashitaka conducts the following safety test regularly: (i) indicator bacteria test, (ii) endotoxin test, (iii) extraction test, (iv) residual eo, ech test.Based on the investigation result, it was a literature reported a successful case of treatment of pancreaticojejunal anastomotic stenosis (pjs) by eus-guided pancreatic duct drainage (eus-pd) using forward viewing ultrasonic endoscope.Since no relevance between the failure of involved product itself or involved product and adverse events was mentioned, no causal relationship was found between the involved product and the reported issue.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 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: 14643138
• MDR Text Key: 293630516
• Report Number: 9681834-2022-00110
• 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,Literature,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2022

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 Model Number: N/A
• Device Catalogue Number: OL-XA25455
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2022
• Initial Date FDA Received: 06/09/2022
• 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: 5FR 9CM PLASTIC STENT (HARMO RAY) -HANAKO MEDICAL; BOUGIE DILATOR (ES DILATOR SOFT TYPE)-ZEON MEDICAL; EZ SHOT 3PLUS; MTW ERCP CATHETER (DUSSELDORF); SIF-H290S; TGF-UC260J (OLYMPUS)
• Patient Outcome(s): Other