MAUDE Adverse Event Report: STERILMED, INC. VIEWFLEX XTRA ICE CATHETER; DIAGNOSTIC INTRAVASCULAR CATHETER

Model Number	RD087031
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned for analysis.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation procedure with a reprocessed viewflex xtra ice catheter and the tip of catheter was broken.When the catheter was removed from the packaging, the broken tip was discovered.There were no lifted or sharp rings, however there was wires and/or braid exposed.No fragments were generated.There was no specific procedural or patient circumstance that contributed to the issue.The procedure was completed with no patient consequence.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation procedure with a reprocessed viewflex xtra ice catheter and the tip of catheter was broken.The returned device (id 01020019 reprocessed under lot 2165391 (1st time reprocessing)) was received on 10-mar-2022 coiled inside a resealable plastic bag.The first 2cm of the distal tip (colored dark-grey), house the transducer and was not meant to be flexed; it is rigid.This section was observed to be fractured and bent.However, the tip was still intact and in one piece; it did not separate or detach in two or more pieces.There were also observed kinks in the shaft.The four-way deflection capabilities of the device were examined, and the device fails to deflect to the proper curvature when compared to the viewflex catheter deflection template.When subjected to additional electrical testing, the device could not complete the evaluation of its transducer on the firstcall 2000, due to the fractured tip.The tip of the catheter was confirmed to be broken.The instructions for use on this model of catheter, states to "inspect the catheter package prior to use.Inspect the catheter carefully for tip integrity and catheter condition.Do not use if the package is opened or device is damaged." there was no provided evidence or indication that the observed kinks in the shaft and the fractured distal tip were present prior to the catheter's removal from its packaging.The current condition of the device could be as a result of its handling after removal from its packaging.Per the failure modes and effects analysis for reprocessed st.Jude viewflex ice catheter, "catheter shaft broken but not detached - distal (inside patient)/(outside the patient)" was listed as a potential hazard.The cause of such a hazard was "damage during procedure." there was no evidence that the observed fractured tip was as a result of reprocessing or its packaging.However, as the product was removed from its packaging and handled in an unknown manner within or outside the operative field, no conclusion as to the cause of the observed damage was determined.The device history record for lot 2165391 was reviewed and the device passed all visual and functional testing prior to being distributed to the customer.A manufacturing record evaluation was conducted and there were no identified internal actions.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4) this is a correction to the initial report h6 medical device problem code should be a0401.

• Brand Name: VIEWFLEX XTRA ICE CATHETER
• Common Device Name: DIAGNOSTIC INTRAVASCULAR CATHETER
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer (Section G): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13660772
• Report Number: 2134070-2022-00007
• Device Sequence Number: 19309408
• Product Code: OWQ
• UDI-Device Identifier: 10888551045216
• UDI-Public: 10888551045216
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K180890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2022

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: 11/01/2022
• Device Model Number: RD087031
• Device Catalogue Number: RD087031
• Device Lot Number: 2165391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 03/10/2022; 07/28/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 03/31/2022; 08/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown