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

Model Number	RD087031
Medical Device Problem Codes	Break (1069); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Uf /importer report #: (b)(4).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).
Event or Problem Description
It was reported that a patient underwent a cryo-ensite ablation procedure with a viewflex xtra ice catheter and a broken tip issue occurred.When this re-sterilized viewflex xtra ice catheter was used, it would not steer and had a sharp angle on it.They removed it from the case, the tip was broken.A brand new catheter was opened and used.No known harm to the patient.Additional information was received.There was no specific procedural or patient circumstance that contributed to the break.No fragments were generated.The issue described with the steering was assessed as non reportable for a steering difficult (deflection) issue.The potential that this issue could cause or contribute to a death, serious injury, or other significant adverse event was remote.The most likely consequence was a procedural delay, if the device has to be replaced.The issue described that it had a sharp angle on it was assessed as mdr reportable for a broken tip issue.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on (b)(6) 2023.The device evaluation was completed on (b)(6) 2023.It was reported that a patient underwent a cryo-ensite ablation procedure with a viewflex xtra ice catheter and a broken tip issue occurred.When this re-sterilized viewflex xtra ice catheter was used, it would not steer and had a sharp angle on it.They removed it from the case, the tip was broken.A brand new catheter was opened and used.No known harm to the patient.Additional information was received.There was no specific procedural or patient circumstance that contributed to the break.No fragments were generated.The product was returned to sterilmed for evaluation.The returned device - id (b)(6) reprocessed under lot 2181932 (1st time reprocessing) - was received coiled inside a resealable decontamination bag.Sterilmed performed visual inspection and functional test on the returned device.Visual inspection was conducted and it is observed that the distal tip, which houses the transducer, is 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 tip of the catheter is confirmed to be broken.Deflection and steering testing was conducted, in accordance with sterilmed procedures.The catheter deflected correctly, and returned to its neutral position; no steering or deflection issues were detected during the analysis.The steering event described could not be confirmed.As part of its functional testing, the transducer was tested, and the sensor array values were found to be outside of the acceptance values, possible cause is damaged transducer as the tip is fractured.The instructions for use contain the following information that should be considered: do not bend, kink, stretch, or forcefully wipe the catheter.These actions may damage the catheter.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.Return both knobs to the neutral position to straighten the distal catheter tip before removing the catheter from the heart.It was reported that the occurrence of the quality event is intra-operative.It is also noted there was no harm to the patient.It is unclear if the reported condition was observed before or after use in the case.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.With the information available the contributing factors to the observed failure mode cannot be determined and the root cause of the failure mode remains unknown.It should be noted that product failure could be caused by other factors, including reasonably foreseeable misuse.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.There is no evidence that the observed fractured tip is a result of reprocessing or its packaging.The dhr for lot 2181932 was reviewed and the device passed all visual inspection and functional testing prior to being distributed to the customer.A manufacturing record evaluation was performed and no internal actions related to the complaint were found during the review.As part of sterilmed¿s quality process all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: -investigation findings: no device problem found (c19)/ investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿steering difficult (deflection) issue¿.-investigation findings: fracture problem (c070603) / investigation conclusions: reasonably foreseeable misuse (d1108) / component code: tip (g04129)were selected as related to the customer¿s reported ¿ broken tip issue¿.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16773515
• Report Number: 2134070-2023-00014
• Device Sequence Number: 17864779
• Product Code: OWQ
• UDI-Device Identifier: 10888551045216
• UDI-Public: 10888551045216
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2023

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: 12/13/2023
• Device Model Number: RD087031
• Device Catalogue Number: RD087031
• Device Lot Number: 2181932
• 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: 03/24/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN BRAND CATHETER
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 98 KG