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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. THERMODILUTION CATHETER, 7FR 4 LUMEN CATHETER, INTRAVASCULAR, DIAGNOSTIC

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DEROYAL INDUSTRIES, INC. THERMODILUTION CATHETER, 7FR 4 LUMEN CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number DTD1704HX
Device Problems Defective Device (2588); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/23/2017
Event Type  malfunction  
Manufacturer Narrative
Root cause: the product is relabelled by deroyal industries, inc. The returned product was forwarded to the vendor / initial manufacturer (biomedical sales international) along with a supplier corrective action request. A root cause for the reported issue cannot be determined at this time. Deroyal is waiting for the completed scar to be returned. Corrective active: a scar and notice of incidence was corresponded to the vendor / intial manufacturer. Investigation summary. An external complaint was received reporting that, when an 7f thermodiltion catheter was being used for right and left heart catheterization, the health professional was not successful in getting a wire through the swan resulting in obtaining less information than deemed necessary. Description provided by the health professional performing the procedure: "right and left heart catheterization. We had four pts that we could not get a wire through the swan and we ended up with less information than was needed. One patient used 3 different swans and that case went on for almost 3 hours. There were no injuries to any patients. " a sample was returned, but deroyal forwarded it to the vendor / initial manufacturer of the device. The issue has been relayed to the vendor / intial manufacturer along with a scar. The investigation is incomplete at this time. When new and critical information is provided a follow up report will be submitted.
 
Event Description
********************************* >> quality issue information << ********************************* ----------------------- *** product details *** ----------------------- product id: dtd1704hx - thermodilution catheter, 7fr 4 lumen. Lot/serial #: h170100056 << warning - not found in jde!!! quantity: 20 pk. How was product acquired? not entered. ----------------------------- *** quality issue details *** ----------------------------- date of occurrence: 08/23/2017. When did quality issue occur? during use. Who was using or operating the product when the quality issue occurred? health professional. Was a medical procedure involved? yes. Name of medical procedure: right and left heart catheterization. Did the quality issue cause a delay in the medical procedure? yes (please provide length of delay and any other details about the procedure in the detailed description field below). Detailed description of quality issue: one patient used 3 different swans and the case went on for almost 3 hours. How was the quality issue was identified? by actual use. How was the product being used? right and left heart catheterization. Was it the initial use of the product? no. Was the product modified from the original condition supplied by deroyal? no. Was the product connected to or used in conjunction with other devices or equipment? no. ----------------------- *** outcome details *** ----------------------- outcome(s) attributed to quality issue: none. Person(s) affected by outcome(s) checked above: patient; facility employee. Known pre-existing condition(s) of person(s) affected: none specified. Was the incident reported to the fda? no. Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: right and left heart catheterization. We had four pts that we could not get a wire through the swan and we ended up with less information than was needed. One patient used 3 different swans and the case went on for almost 3 hours. There were no injuries to any patients.
 
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Brand NameTHERMODILUTION CATHETER, 7FR 4 LUMEN
Type of DeviceCATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
DEROYAL INDUSTRIES, INC.
1703 hwy 33 south
new tazewell TN 37825
Manufacturer (Section G)
DEROYAL INDUSTRIES, INC.
1703 hwy 33 south
new tazewell TN 37825
Manufacturer Contact
sarah bennett
200 debuck lane
powell, TN 37849
MDR Report Key6902127
MDR Text Key89635005
Report Number1060680-2017-00018
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K911710
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 09/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDTD1704HX
Device Lot NumberH170100056
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/29/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/28/2017 Patient Sequence Number: 1
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