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

Model Number 04402SM

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 04402sm, lot# fa58555, serial# (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that prior to a radiofrequency (rf) procedure, during the preparation, a foreign material on the upper tray of the packaging of the rf catheter was observed.It was further noted that the foreign material was already inside the packaging before it was opened.The catheter was replaced with resolve.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product analysis: the device package was returned and analyzed.Visual inspection confirmed evidence of foreign material within the inner sterile package.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction: product analysis: the device package was returned and analyzed.Visual inspection confirmed evidence of foreign material within the inner sterile package.Infrared spectroscopic analysis was performed on the foreign material.The foreign material was an organic compound with an amide bond, it was consistent with the lysozyme which was one of biological enzyme.Lysozyme exists in body fluids, tissues and secretions.Therefore, it was possible that the foreign material on the tray was an enzyme in a blood.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

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: 7650397
• MDR Text Key: 112728699
• Report Number: 2649622-2018-10670
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K981642
• 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,Followup,Followup,Followup
• Report Date: 10/03/2018

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 Expiration Date: 12/11/2019
• Device Model Number: 04402SM
• Device Catalogue Number: 04402SM
• Device Lot Number: FA58555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 07/26/2018; 07/31/2018; 08/08/2018; 08/08/2018
• Supplement Dates FDA Received: 07/27/2018; 08/02/2018; 10/02/2018; 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2017
• 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