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 Patient Involvement (2645)
Date of Event	10/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that black spots were observed on the coaxial umbilical cable in the unopened package.There was no patient involvement.
Additional Manufacturer Narrative
Event summary: upon visual inspection of coaxial umbilical cable 203cx, results showed the coaxial umbilical cables was intact with no apparent issues.Coaxial cable 203cxc / 05734 failed the performance test due to foreign material inside the coax umbilical.In conclusion, the reported coax issue in packaging has been confirmed through testing.The coaxial umbilical cable failed the returned product inspection due to the foreign material inside the coax.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: 7024010
• Report Number: 3002648230-2017-00607
• Device Sequence Number: 2037073
• Product Code: LPB
• UDI-Device Identifier: 00643169950146
• UDI-Public: 00643169950146
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P020045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2018

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: 07/19/2019
• Device Model Number: 203CX
• Device Catalogue Number: 203CX
• Device Lot Number: 05734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Initial Date Received by Manufacturer: 10/19/2017
• Supplement Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 11/13/2017
• Supplement Report FDA Received Date: 01/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1