MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA RADIFOCUS GUIDEWIRE

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

Patient Problems Hematoma (1884); Blood Loss (2597)

Event Date 01/08/2016

Event Type  Injury  

Manufacturer Narrative

Udi no.- not yet required.The actual sample was not returned to the manufacturing facility for evaluation.With no product code or lot # information the investigation was limited to user facility information and prevented a meaningful review of production or complaint records.There is no evidence that this event was related to a device defect or malfunction.Based on the available information a cause and effect relation between this product and the reported issue was unable to be definitively determined.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.Device not returned to manufacturer.

Event Description

The user facility reported that during removal of the radial sheath it may have caused an issue with the patient's radial artery.Follow up communication with the user facility confirmed the following information: the patient experienced a radial artery issue; post diagnostic catheterization; a hematoma developed immediately after the tr band was removed; pressure was applied; the bleeding was successfully controlled; the area in question was iced and ace wrapped; blood loss was less than 250ml; the procedure was successfully; and the patient was reported as doing fine.

• Brand Name: RADIFOCUS GUIDEWIRE
• Type of Device: GUIDEWIRE
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer Contact: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 5681525
• MDR Text Key: 45982933
• Report Number: 9681834-2016-00136
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2016
• 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: TR BAND
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Weight: 57