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

Model Number	RD087031
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a procedure with a viewflex xtra ice catheter, and a broken tip issue occurred.Opened the package and went to put catheter in the body and the tip of the viewflex xtra ice catheter was completely broken in half.It was noticed before inserting into the patient.There was no patient consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The event was assessed as mdr reportable for a broken tip issue.
Additional Manufacturer Narrative
The device has not yet been returned for analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by sterilmed, inc., or its employees that the report constitutes an admission that the product, sterilmed, inc., or its employees caused or contributed to the potential event described in this report.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).
Additional Manufacturer Narrative
It was reported that a patient underwent a procedure with a viewflex xtra ice catheter, and a broken tip issue occurred.Opened the package and went to put catheter in the body and the tip of the viewflex xtra ice catheter was completely broken in half.It was noticed before inserting into the patient.There was no patient consequence.The bwi product analysis lab received the device for evaluation on 19-oct-2022.The investigation was completed on 28-oct-2022.The returned device - id 01151827 reprocessed under lot 2173021 (1st time reprocessing) - was received coiled inside a resealable plastic bag.There is an observed kink in the catheter shaft.The first 2cm of the distal tip (colored dark-grey), which houses the transducer and is not meant to be flexed and is rigid, is observed to be fractured and bent.However, the tip is still intact and in one piece.It did not separate or detach in two or more pieces.The deflection capabilities of the device were examined and the distal area of the shaft deflects to the proper curvature when compared to the viewflex catheter deflection template.The tip of the catheter is confirmed to be broken, outside of the patient.The instructions for use on this model of catheter states to, "inspect the catheter carefully for tip integrity and catheter condition." also, "hold the catheter 1 to 2 cm from the introducer valve and feed it into the introducer slowly to prevent buckling of the catheter tip." it was reported that the occurrence of the quality event is intra-operative, but prior to insertion into the patient.It is unclear if the tip appeared good within its package and was broken as it was being removed from the packaging.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.There is insufficient evidence 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, the kinked shaft and fractured tip, appears to be a result of improper handling after removal from its packaging.Per the failure modes and effects analysis (fmea) for reprocessed st.Jude viewflex ice catheter, "catheter shaft broken but not detached - distal (inside patient)/(outside the patient)" is listed as a potential hazard.The cause of such a hazard is "damaged during procedure." there is no evidence that the observed fractured tip is as a result of reprocessing or its packaging.As well, as the product was removed from its packaging and was being handled in an unknown manner within the operative field, no conclusion as to the cause of the observed damage is determined.The device history record for lot 2173021 was reviewed and the device passed all visual inspection and functional testing prior to being distributed to the customer.An mre 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 reference number: (b)(4).

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15585174
• Report Number: 2134070-2022-00019
• Device Sequence Number: 7142473
• Product Code: OWQ
• UDI-Device Identifier: 10888551045216
• UDI-Public: 10888551045216
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2022

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: 03/28/2023
• Device Model Number: RD087031
• Device Catalogue Number: RD087031
• Device Lot Number: 2173021
• 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: 09/20/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2022
• 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