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

Catalog Number	R10135936
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned for analysis.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation procedure with a reprocessed acunav 8f-90 sms catheter, and the sterile packaging for the catheter was damaged, as there was some tearing and the package was open.In addition, the catheter shaft was also bent out of the packaging.There were no exposed wires.The catheter was replaced, and the issue resolved.There was no patient contact with the device and no patient consequence.The procedure was not altered due to this issue.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation procedure with a reprocessed acunav 8f-90 sms catheter, and the sterile packaging for the catheter was damaged, as there was some tearing and the package was open.In addition, the catheter shaft was also bent out of the packaging.The device was returned for analysis on 9/27/2019.The complaint device was submitted to full functional testing.The device passed its full electrical testing as well as its mobility testing.No defect was found with any portion of the device's performance or functionality.As such the account's complaint could not be confirmed or duplicated.The device arrived at sterilmed without any of its original packaging.As such no analysis of the packaging could be conducted.A manufacturing record evaluation was performed, no discrepancies were noted and no non-conformances 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).

• Brand Name: IMAGING CATHETER
• Common Device Name: REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 8913239
• Report Number: 2134070-2019-00143
• Device Sequence Number: 1606768
• Product Code: OWQ
• UDI-Device Identifier: 10888551044349
• UDI-Public: 10888551044349
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K043453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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: 03/25/2020
• Device Catalogue Number: R10135936
• Device Lot Number: 2095887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1