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

Model Number 203CX

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/31/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that prior to a cryo ablation procedure, a hair was observed on the coaxial cable when opening the package.The cable was replaced with resolve and the procedure was completed with cryo.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Event summary: visual inspection of coaxial umbilical cable showed the cable was intact with no apparent issues.Coaxial cable, 203cx / 88259, passed the performance testing with lab test catheter.No foreign material was observed inside the packaging of coax umbilical cable.In conclusion, the reported coaxial umbilical cable packaging issue has been not confirmed through testing.If information is provided in the future, a supplemental report will be issued.

• Brand Name: COAXIAL UMBILICAL CABLE
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7899315
• MDR Text Key: 121454470
• Report Number: 3002648230-2018-00680
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P020045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2018

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
• Device Operator: Health Professional
• Device Model Number: 203CX
• Device Catalogue Number: 203CX
• Device Lot Number: 88259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/31/2018
• Initial Date FDA Received: 09/21/2018
• Supplement Dates Manufacturer Received: 10/16/2018
• Supplement Dates FDA Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1