MAUDE Adverse Event Report: STERILMED, INC. CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM; REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER

Model Number	ACU10135936
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device investigation has been completed.The account returned the impacted device [id (b)(4) reprocessed under lot 2139875; 1st time reprocessing] without any of the related packaging or label.No other packaging for this catheter (pouch, clayboard box, original shipping container) were returned for evaluation.No other additional evidence, such as photographs showing the damage to packaging, were provided.As such, there is no determination, and it is not confirmed, that the sterility of the package was compromised, or that there were holes in the packaging.The device history record for lot 2139875 shows that the device and packaging 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.Manufacturer's ref.Number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure and there was a small hole in the packaging of the acunav catheter.The catheter was exchanged, and the issue was resolved.The case continued without any further incident.Additional information was received on december 16, 2020.The puncture was located on the top of the plastic pouch sheathing the acunav.The hole was about the size of the diameter of a large needle.It was found after removing the surrounding box.It is not believed the issue could have been caused by shipping as the box should have protected the plastic.Per the additional information received, this event has been assessed as mdr reportable due to the compromise in the sterility of the catheter.

• Brand Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM
• Common Device Name: REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 11047031
• Report Number: 2134070-2020-00014
• Device Sequence Number: 13751421
• Product Code: OWQ
• UDI-Device Identifier: 10888551004732
• UDI-Public: 10888551004732
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K043453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/26/2021
• Device Model Number: ACU10135936
• Device Catalogue Number: ACU10135936
• Device Lot Number: 2139875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1