MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA TR BAND; VASCULAR CLAMP

Catalog Number XX-RF06

Device Problems Air Leak (1008); Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

Udi no.- not required to be registered with the fda.The actual device was returned to the manufacturing facility for evaluation.Visual inspection found that the air injection tube had been fractured.The air injection tube was measured and found to have been stretched.Magnifying inspection of the lateral side of the air injection tube around the fracture confirmed no anomalies.Magnifying inspection of the fracture cross-section of the air injection tube revealed a stripe-like pattern crossing the surface from the outside circumference to the inside circumference.Electron microscopic inspection of the fracture cross-section of the air injection tube found several stripe-like patterns on the surface as well as several clearer stripes crossing the surface from the outside circumference to the inside circumference.The outside diameter of the air injection tube was found to be thinner along the total length of the tube than that of the current sample from the involved product code.Simulation testing was conducted on a sample from the involved product code.The air injection tube of the sample was exposed to a pulling force until it became fractured.Magnifying microscopic inspection of the fracture cross-section of the air injection tube found several stripe-like patterns had been generated on the surface with several stripes crossing the surface from the outside circumference to the inside circumference.The total length of the tube was measured and found to have been stretched.The state of the sample was found to be similar to that of the actual sample.A review of the device history record and the product release decision control sheet of the product code/lot combination was conducted with no relevant findings.A search of the complaint file find no other report with the involved product code/lot number combination of this nature.There is no evidence that this event was related to a device defect or malfunction.While the exact cause of the reported event cannot be definitively determined based on the available information, it is likely the air injection tube of the actual device was subjected to an excessive pulling force, resulting in the reported fracture.(b)(4).All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

Event Description

The user facility reported a tube fracture on the tr band device during a procedure.Follow up communication with the user facility confirmed the following information: the patient was taken to the ward with the actual sample applied to the wrist; when the nurse checked, while the patient stayed on rest, it was noted that the air injection tube of the actual sample had been fractured and the balloons had been deflated; there was some bleeding from the patient's access site, an exact amount was not reported; hemostasis treatment was conducted on the patient in the ward; and the patient was not harmed.

• Brand Name: TR BAND
• Type of Device: VASCULAR CLAMP
• 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: 6491012
• MDR Text Key: 72795847
• Report Number: 9681834-2017-00067
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070423
• 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: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: XX-RF06
• Device Lot Number: 160601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2017
• Initial Date FDA Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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