MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP COAXIAL UMBILICAL CABLE; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	203CX
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that prior to a cryo ablation procedure, when the packaging was opened, there was a feather sticking to the connector of the coaxial umbilical cable.The coaxial umbilical cable was replaced with a new one.The case was completed with cryo.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Event summary: upon visual inspection of coaxial umbilical cable 203cx, results showed the devices were intact with no apparent issues.Coaxial cables 203cx / 96519 failed performance test due to leak at the coax connector adhesive.In conclusion, the reported issue (feather in packaging) has been not confirmed through testing.The coaxial cable failed performance test due to leak at the coax connector adhesive.If information is provided in the future, a supplemental report will be issued.

• Brand Name: COAXIAL UMBILICAL CABLE
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• MDR Report Key: 6498196
• Report Number: 3002648230-2017-00167
• Device Sequence Number: 1009986
• Product Code: LPB
• UDI-Device Identifier: 00643169352520
• UDI-Public: 00643169352520
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P020045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/05/2017

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: 12/06/2018
• Device Model Number: 203CX
• Device Catalogue Number: 203CX
• Device Lot Number: 96519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Initial Date Received by Manufacturer: 03/23/2017
• Supplement Date Received by Manufacturer: Not provided; 07/05/2017; 07/05/2017
• Initial Report FDA Received Date: 04/17/2017
• Supplement Report FDA Received Date: 06/28/2017; 07/27/2017; 09/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1