MAUDE Adverse Event Report: STERILMED, INC. IMAGING CATHETER; REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER

Catalog Number R10135910

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Tamponade (2226)

Event Date 02/10/2021

Event Type  Injury  

Manufacturer Narrative

The device has not yet been returned for analysis.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a female patient born in (b)(6) underwent a paroxysmal atrial fibrillation ablation procedure with a reprocessed acunav imaging catheter and the patient suffered cardiac tamponade requiring pericardiocentesis.The patient suffered a pericardial effusion at the end of the procedure, after ablation had been completed.The patient's blood pressure dropped, and the physician scanned with an intracardiac echocardiogram and saw an effusion.Pericardiocentesis was performed and 200 ml of "dark red blood" was removed and auto-transfused back to the patient.The doctor suspects that there was a perforation on the right side of the heart.The patient was awake and stable and was admitted overnight.The patient has fully recovered and been discharged home.The physician suspects that there was a perforation on the right side of the heart and the issue was probably caused by the ultrasound (reprocessed acunav) or his catheter (boston scientific).Transseptal puncture was performed with a cook needle.Settings during the procedure were: max wattage: 30 w, total ablation time: 22 min, 39 sec, 275ml fluid to the patient via ablation.Irrigation settings were per instructions for use, visitag settings: 3 mm, 3 ms, 25% at 4g.Max tag index 519, force was visualized with graph, dashboard, vector and visitags colored by tag index.There was no evidence of a steam pop.

Manufacturer Narrative

It was reported that a female patient born in 1946 underwent a paroxysmal atrial fibrillation ablation procedure with a reprocessed acunav imaging catheter and the patient suffered cardiac tamponade requiring pericardiocentesis.The account returned one r10135910 linked to lot: 2148038.The device was submitted to full functional testing.The device triggered no errors during its identity testing, or during its sensitivity testing.No weak or dead elements were detected.The complaint device also passed its mobility testing.No issues were encountered with the mobility of the device, and there were no structural abnormalities noted on the visual inspection of the device.No electrical error was reported at the account concerning the performance of the imaging catheter in the field.The full electrical testing prior to the shipment to the field was reviewed, and it was noted that the device passed full electrical testing, showing no errors or issues prior to its shipment.As the device was removed from its packaging, and handled in the field, as well as being coiled for its return shipment, the imaging catheter failed its visual straightness testing.However, no issues with the mobility of the imaging catheter could be found.Based on this evidence the complaint device passed its evaluation as well as indicating that the device would be expected to perform as designed in the field.A manufacturing record evaluation was conducted for lot: 2148038 and no non-conformances were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4) correction to initial report, the device was received for analysis on february 25, 2021.In the initial report it was incorrectly reported as not returned.Section d9 has been updated.

• Brand Name: IMAGING CATHETER
• Type of Device: REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 11440863
• MDR Text Key: 244172262
• Report Number: 2134070-2021-00003
• Device Sequence Number: 1
• Product Code: OWQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2022
• Device Catalogue Number: R10135910
• Device Lot Number: 2148038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: 6FR CS,D,10 POLE,12 PIN,AUTOID.; BOSTON SCIENTIFIC HIS CATHETER.; CARTO 3 SYSTEM.; COOK NEEDLE.; LASSO NAV 2515,22P SPLITHANDLE.; THMCL SMTCH SF BID, TC, D-F.; UNK_PREFACE SHEATH.
• Patient Outcome(s): Life Threatening; Required Intervention