MAUDE Adverse Event Report: MPRI RF CONDUCTR¿; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 07886044

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 11/25/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that while doing touch ups with radiofrequency(rf) after a cryo procedure, the rf temperatures were not as expected.The power was increased without resolve.The case was aborted while the patient was under general anesthesia.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the catheter, (b)(4) with lot number: fa71614 was returned and analyzed.External visual inspection of the catheter showed the device was intact with no apparent issues.The returned catheter passed performance tests.The product issue reported (temperature issue) is not likely to cause or contribute to a death or serious injury; however, the risk of the patient being under general anesthesia without full therapeutic effect is the adverse event being reported.The decision to abort the procedure without use of alternate therapy was based upon the medical judgment of the physician.The catheter passed the returned product inspection.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RF CONDUCTR¿
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9489928
• MDR Text Key: 171863166
• Report Number: 2649622-2019-23968
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P930029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2021
• Device Model Number: 07886044
• Device Catalogue Number: 07886044
• Device Lot Number: FA71614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 02/25/2020
• Supplement Dates FDA Received: 03/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other