MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES B8634, UROWIRE SIX PACK 6/BX; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	B8634
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has just received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Procedure performed: unknown.Suspected faulty product when opened out of sterile pack before use.No further information is known and was not passed on my medical staff to clinical procurement.Additional information received via email from account manager on wednesday 19jun2019: the guide wire had been reversed loaded ( incorrectly by manufacture), the hydrophilic coating of wire shredded inside kidney and had to be carefully removed before surgery could recommence.Patient status: non.Type of intervention: the hydrophilic coating of wire shredded inside kidney and had to be carefully removed before surgery could recommence.
Event or Problem Description
Procedure performed: unknown.Suspected faulty product when opened out of sterile pack before use.No further information is known and was not passed on my medical staff to clinical procurement.Additional information received via email from account manager on wednesday 19jun2019: the guide wire had been reversed loaded ( incorrectly by manufacture), the hydrophilic coating of wire shredded inside kidney and had to be carefully removed before surgery could recommence.Patient status: non.Type of intervention: the hydrophilic coating of wire shredded inside kidney and had to be carefully removed before surgery could recommence.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection was performed on the event unit and engineering confirmed the tubing had been cut and stripped off the guidewire.Damage was also observed on the core wire.Based on the description of the event and evaluation of the returned unit, it is likely that the unit came into contact with a sharp edge on an instrument, which caused the coating to separate from the unit.

• Brand Name: B8634, UROWIRE SIX PACK 6/BX
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8773599
• Report Number: 2027111-2019-00507
• Device Sequence Number: 1708587
• Product Code: EZB
• UDI-Device Identifier: 00607915113858
• UDI-Public: (01)00607915113858(17)210523(30)01(10)1325966
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K944135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/23/2021
• Device Model Number: B8634
• Device Catalogue Number: 100996701
• Device Lot Number: 1325966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1