MAUDE Adverse Event Report: STERILMED, INC. ST JUDE MEDICAL AGILIS NXT STEERABLE INTRODUCER, BI-DIRECTIONAL, MEDIUM CURL-22.; REPROCESSED CATHETER INTRODUCER

Model Number	STJ408310
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product analysis lab received the device for evaluation.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 st jude medical agilis nxt steerable introducer, bi-directional, medium curl-22 and the flushing side port of the sheath broke off.The side port broke off just before going into the patient¿s body, therefore the only portion of the device used on the patient was the wire.There was no difficulty noted prior to break and there were no circumstances noted that contributed to the break, it is reported to have just popped off.This event has been assessed as mdr reportable.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation ablation procedure with a reprocessed st jude medical agilis nxt steerable introducer, bi-directional, medium curl-22 and the flushing side port of the sheath broke off.The introducer was returned with the hub's flushing port whole and intact, and the irrigation tubing was detached and not returned.No dilator or guidewire were returned, as well.The introducer was also returned with significant biological contaminants on its surfaces, indicative of handling within the field and, possible, patient contact.The device was examined under lighted magnification.It is observed that the irrigation tube is separated in twain, with part of the tubing still attached to the interior of the hub's flushing port, by the adhesive.It is assessed that there is no leakage between tubing and the hub pin.From proximal side, seals appear to be assembled correctly and are in good shape.The point of separation indicates some unknown type of external manipulation, like being pulled apart or use of sharp instrument.There is no indication that the tubing ¿popped off¿ and there is no indication the observations are related to its reprocessing.As the hub's flush port is whole and intact; it is not broken off, the reported issue is not confirmed.The clear tubing is noted as being damaged and detached.The returned device was reprocessed under lot 2155618 (first time reprocessing).The device history record was reviewed, and the device passed all visual and functional testing prior to being distributed to the field.A manufacturing record evaluation was conducted and there were no identified nonconformances.Manufacture and expiration dates obtained therefore d4 and h4 were updated.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: ST JUDE MEDICAL AGILIS NXT STEERABLE INTRODUCER, BI-DIRECTIONAL, MEDIUM CURL-22.
• Common Device Name: REPROCESSED CATHETER INTRODUCER
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 12516824
• Report Number: 2134070-2021-00020
• Device Sequence Number: 12051925
• Product Code: PNE
• UDI-Device Identifier: 10888551044929
• UDI-Public: 10888551044929
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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
• Report Date (Section B): 10/14/2021

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: 05/05/2022
• Device Model Number: STJ408310
• Device Catalogue Number: STJ408310
• Device Lot Number: 2155618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1