MAUDE Adverse Event Report: MPRI STABLEMAPR; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 04402SM

Device Problem No Apparent Adverse Event (3189)

Patient Problems Pain (1994); Cardiac Perforation (2513)

Event Date 02/09/2016

Event Type  Injury  

Manufacturer Narrative

Product event summary: the ep catheter was returned and analyzed.The analyst noted: the shaft is kinked and distorted at various locations near the distal end of catheter.Control wire is broken and poked thru shaft at 95cm(from handle), blood visible on shaft, damaged during procedure.No control or movement possible.Analysis further indicated that the mechanical wire had penetrated the lumen wall.There was also a visual finding of blood.

Event Description

It was reported that during an ablation procedure while the mapping catheter was in the right atrium along the tricuspid valve the catheter was unable to be moved.The tip of the catheter had become trapped at the entrance of the inferior vena cava.After some maneuvering the catheter was able to be removed.The patient experienced transient back pain, and a venogram was performed revealing a small dissection of the wall.There were no hemodynamic consequences and no intervention or extended hospitalization was required.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

• Brand Name: STABLEMAPR
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5711944
• MDR Text Key: 47083330
• Report Number: 2649622-2016-06074
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: DRF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2017
• Device Model Number: 04402SM
• Device Catalogue Number: 04402SM
• Device Lot Number: FA52777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2015
• 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