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

Model Number N/A

Device Problem Migration (4003)

Patient Problems Hemorrhage/Bleeding (1888); Pancreatitis (4481)

Event Type  Injury  

Event Description

Per literature review: endoscopic transpapillary gallbladder drainage for the management of acute calculus cholecystitis patients unfit for urgent cholecystectomy (b)(6) 2020: adverse events such as pancreatitis, post-est bleeding, stent migration, recurrence of acute calculus cholecystitis and acute cholangitis was reported, and visiglide was listed as one of the involved devices; however, no defect of the product itself was mentioned in the literature.Post-operative pancreatitis was reported, and visiglide was among the devices used.No device malfunctions were reported.The procedure outcome was not reported.The final patient impact was death; however, the patient death was not attributed to the defect of the device.

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: 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.Street address - 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 manufacturing records or product-release judgement records could not be performed since the involved lot number was unknown.Regarding the involved product code, no similar report was received over the past five years ((b)(6) 2017 - (b)(6) 2022).This product has undergone (b)(4) compliant biological safety evaluation (cytotoxicity, skin sensitization, intradermal reaction, acute toxicity reaction, exothermic substance, and hemolytic) at the product design stage.Ashitaka conducts the following safety test regularly.I) indicator bacteria test; ii) endotoxin test; iii) extraction test; iv) residual eo, ech test.Regarding the involved product code, review of the complaint records for the past five years (b)(6) 2017 - (b)(6) 2022) found no similar report.The details on the occurrence condition of this case was unknown, no causal link between the reported issue and the product in question was not clarified.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 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: stephanie handy ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 14204548
• MDR Text Key: 290053098
• Report Number: 9681834-2022-00067
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/26/2022

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-XA25273M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2022
• Initial Date FDA Received: 04/26/2022
• 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: JF-260V (OLYMPUS).; LIGUORY (COOK MEDICAL).; SPYGLASS DS (BOSTON SCIENTIFIC).; ZIMMON (COOK MEDICAL).
• Patient Outcome(s): Other