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

Catalog Number	RD087031
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned for analysis.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 an atrial fibrillation ablation procedure with a reprocessed viewflex xtra ice catheter and during the procedure, the tip of the catheter broke.The device was able to be removed.The tip was still attached to the rest of the catheter by the internal components.There was no physical damage or any other issue observed on the package of the device.There was no patient consequence reported.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation ablation procedure with a reprocessed viewflex xtra ice catheter and during the procedure, the tip of the catheter broke.Product was not returned for analysis and the customer complaint cannot be confirmed.The device history record for lot 2231092 was reviewed and there were no identified manufacturing deficiencies or internal action.All finished goods devices had passed all visual and functional criteria prior to distribution.If the device is made available, the investigation will be updated as applicable.This issue is being further addressed through sterilmed's quality system and actions are being taken on the supplier's side.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: NA
• 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22816378
• Report Number: 2134070-2025-00017
• Device Sequence Number: 8703636
• Product Code: OWQ
• UDI-Device Identifier: 10888551045216
• UDI-Public: (01)10888551045216(17)260512(10)2231092
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 05/12/2026
• Device Catalogue Number: RD087031
• Device Lot Number: 2231092
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2025
• 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