MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES B8634, UROWIRE SIX PACK 6/BX; EZB

Model Number	B8634
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device has two fda product codes: ezb, kny.The incident device is anticipated to return.A follow-up report will be provided upon completion of investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.
Event or Problem Description
Cystoscopy, ureteroscopy - "during cystoscopy the blue sheath separated and splintered from the guidewire, dr was unable to use item further." patient status - "fine.".
Additional Manufacturer Narrative
Investigation summary: the event unit was returned to applied medical for evaluation.Upon inspection, engineering confirmed the complainant's experience that the blue coating/tubing had separated from the wire.The root cause of the tubing separation could not be determined.Based on the inspection of the returned unit, it is likely that the tubing was damaged due to interaction with an instrument, possibly the cystoscope.It is possible that when the unit was removed from the scope, it made contact with the edge of the scope, which damaged the tubing and caused it to separate from the wire.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• Brand Name: B8634, UROWIRE SIX PACK 6/BX
• Common Device Name: EZB
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6197130
• Report Number: 2027111-2016-00906
• Device Sequence Number: 717338
• Product Code: EZB
• UDI-Device Identifier: 00607915113858
• UDI-Public: (01)00607915113858(11)181027(30)01(10)1258083
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• PMA/510(K) Number: K944135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2017

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
• Operator of Device: Other
• Device Expiration Date: 10/27/2018
• Device Model Number: B8634
• Device Catalogue Number: 100996701
• Device Lot Number: 1258083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1