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

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.

• Brand Name: THERMODILUTION CATHETER, 7FR 4 LUMEN
• Type of Device: CATHETER, 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 Key: 6902127
• MDR Text Key: 89635005
• Report Number: 1060680-2017-00018
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911710
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/28/2017

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 Model Number: DTD1704HX
• Device Lot Number: H170100056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 09/28/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention