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

Model Number R10439236

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

Patient Problem Cardiac Tamponade (2226)

Event Date 11/27/2020

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 underwent cardiac ablation procedure for atrial fibrillation (afib) with a reprocessed soundstar eco 8fg ultrasound catheter and suffered cardiac tamponade requiring pericardiocentesis.During the mapping phase of the procedure, a cardiac tamponade was noticed as the patient¿s blood pressure dropped.The cardiac tamponade was confirmed by intracardiac and body surface echocardiogram.The medical intervention provided was a pericardiocentesis and approximately 350ml of fluid were removed.The patient was reported to be in stable condition.The physician commented that the event was related to manipulation of the ultrasound catheter as they never came on ablation and the physician saw the patient having blood pressure issues while manipulating the ultrasound catheter.The patient had to stay in the hospital to be monitored for longer than intended and has fully recovered.The transseptal puncture was performed with the baylis needle.Additional mapping was performed with a pentaray catheter that was on a pressure bag.No error messages were observed on equipment.

Manufacturer Narrative

The manufacture date (9/15/2020) and expiration date (9/15/2021) were received.Fields d4 and h4 were updated on this report.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

It was reported that a female patient underwent cardiac ablation procedure for atrial fibrillation (afib) with a reprocessed soundstar eco 8fg ultrasound catheter and suffered cardiac tamponade requiring pericardiocentesis.The lot number and serial was received on 1/4/2021.Section d4 was updated.The device was returned for investigation on 1/8/2021.The investigation has been completed.The returned product (id: 0530101 reprocessed under lot: 2140070 (1st time reprocessing)) was received coiled with observed bends, that could occur because of being coiled.The 4-digit code on the connector's 2-d barcode is 8869, which identifies the product as an 10439236 imaging catheter for use on a ge imaging system.The product is noted to be identified correctly.The device was then submitted to full functional testing, verifying its recognition, mobility, and continuity.The device was able to connect to all equipment and it passed all equipment testing, verifying calibration, location, and signal strength of the sensors and transducer.The deflection capabilities of the device were tested and there was no observed mobility deflection defect.Unable to determine any defect with the device.The device would be expected to perform as designed on the appropriate ge ultrasound system.As device was removed from its packaging, was handled, and used within the operative field, no conclusion could be determined as to the cause for reported event.The device history record for lot: 2140070 was reviewed and the device passed all visual and functional criteria, prior to being distributed to the customer.A manufacturing record evaluation was conducted and there were no identified nonconformances.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

• 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: 11032768
• MDR Text Key: 222287673
• Report Number: 2134070-2020-00015
• Device Sequence Number: 1
• Product Code: OWQ
• UDI-Device Identifier: 10888551045094
• UDI-Public: 10888551045094
• Combination Product (y/n): N
• PMA/PMN Number: K161700
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2020

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: 09/15/2021
• Device Model Number: R10439236
• Device Catalogue Number: R10439236
• Device Lot Number: 2140070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Initial Date Manufacturer Received: 11/27/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 01/04/2021; 02/04/2021
• Supplement Dates FDA Received: 01/28/2021; 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: BAYLIS TRANSSEPTAL NEEDLE.; EZ STEER TCOOL NONNAV TC F-J.; UNK_PENTARAY.; BAYLIS TRANSSEPTAL NEEDLE; EZ STEER TCOOL NONNAV TC F-J; UNK_PENTARAY
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention