MAUDE Adverse Event Report: STERILMED, INC. CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM; REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER

Catalog Number	ACU10135910
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Three photos were provided.The photos show wrinkling along parts of the package, but there is no observed or determined breach in the packaging that would compromise sterility.The information provided by the photo is insufficient to determine if there is any failure in the packaging.The reported issue of compromised sterility is not confirmed.One photo shows a bend in the shaft, as product has been removed from its clayboard box, it's not determined when or how that damage might have occurred.The product is packaged in a manner to restrict movement of the product, to prevent such damage from occurring.To duplicate the finding would require to either remove the device from its white clayboard box and store and/or handle the device in a manner that leads to that damage, or the white clayboard carton would have suffered, and thus show, significant damage prior to removing the device from the package; this being caused by either shipping damage or damage caused to the carton after its removal from the shipping container.As product was removed from its clayboard box and no additional information on the condition of the shipping container was received, no conclusion as to the timing and cause of the observed damage in the photo can be determined.A manufacturing record evaluation was performed for the finished device lot# (b)(4), and no non-conformances were identified.Once/if the product and packaging are received, an evaluation will be conducted.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent a procedure with a reprocessed acunav diagnostic ultrasound catheter and the sterility was compromised.During pre-op set up, when the catheter box was opened, the inside package was bent, the catheter was bent, and the package sterility was compromised.Catheter was never used and did not come in contact with the patient as it was damaged and no longer sterile.An alternative device was used to complete the procedure.The intent of the procedure was not altered due to this event.There was no patient consequence.
Additional Manufacturer Narrative
It was reported that a patient underwent a procedure with a reprocessed acunav diagnostic ultrasound catheter and the sterility was compromised.The device and a label were returned.The label appears to have been cut from the original packaging; the rest of the packaging was not returned.It was noted that the package was "torn and bent" and compromised.However, as the remainder of any original packaging was not returned, this compromised condition could not be evaluated and verified.This aspect of the reported issue is not confirmed.A photo investigation was also conducted on provided photographs by the.In the photo, there was a bend observed by the flag barcode label.Upon examining the returned device, which was returned outside its packaging and coiled, there are two observed kinks in the shaft.One that appears in the same location as viewed in the photograph, and another 2 cm down the shaft.The already confirmed bend in the shaft is further corroborated by the visual examination of the actual involved device.However, as the device has been removed from the package and returned coiled, no conclusion as to the cause of this damage or when it may have occurred can be determined.The device history record was reviewed, and the product had passed all visual and functional criteria prior to being distributed to the customer.A manufacturing record evaluation was conducted for the finished device lot# 2100112, and no non-conformances were identified.Manufacturer's ref.No:(b)(4),.

• Brand Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT 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: 9418690
• Report Number: 2134070-2019-00149
• Device Sequence Number: 11190394
• Product Code: OWQ
• UDI-Device Identifier: 10888551004725
• UDI-Public: 10888551004725
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K043453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2019

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: 04/29/2020
• Device Catalogue Number: ACU10135910
• Device Lot Number: 2100112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1