MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R50, 12X130 KII BALLOON BLNT TIP 6/BX; GCJ

Model Number	1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the event.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.This report represents the combined initial and final.
Event or Problem Description
Procedure performed: unk.Event description: mdr report number (b)(4): edge of kii balloon blunt tip system broke off during surgery.Type of intervention: na.Patient status: unk.

• Brand Name: C0R50, 12X130 KII BALLOON BLNT TIP 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6712905
• Report Number: 2027111-2017-01910
• Device Sequence Number: 2013758
• Product Code: GCJ
• UDI-Device Identifier: 00607915116460
• UDI-Public: (01)00607915116460(17)190505(30)01(10)1269514
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: 1
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/05/2019
• Device Model Number: 1
• Device Catalogue Number: 1
• Device Lot Number: 1269514
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 07/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1