MAUDE Adverse Event Report: STERILMED, INC. EP DIAGNOSTIC CATHETER DYNAMIC XT STEERABLE DECAPOLAR LARGE; CATHETER, RECORDING, ELECTRODE, REPROCESSED

Model Number	BAR201101
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2019
Type of Reportable Event	Malfunction
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.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial flutter ablation procedure with a reprocessed ep diagnostic catheter dynamic xt steerable decapolar large catheter and the catheter curve was stuck in a deflected position with full tension on curved tip and could not be relaxed.A new dynamic decapolar catheter was used to complete the procedure and the intent of the procedure was not altered as a result of this event.There was no patient consequence.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial flutter ablation procedure with a re-processed ep diagnostic catheter dynamic xt steerable decapolar large catheter and the catheter curve was stuck in a deflected position with full tension on curved tip and could not be relaxed.Additional information was received on 1/23/2020 that the device is no longer available.Therefore, we could not confirm the deflection issue because the product said to be involved was not received for evaluation and visual and functional inspections could not be performed.A manufacturing record evaluation was conducted for the finished device lot 2098242 and no non-conformances were identified.Once/if device is received, the complaint will be re-opened and a complete evaluation will be conducted.Manufacturer's ref.No: (b)(4).

• Brand Name: EP DIAGNOSTIC CATHETER DYNAMIC XT STEERABLE DECAPOLAR LARGE
• Common Device Name: CATHETER, RECORDING, ELECTRODE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 9496263
• Report Number: 2134070-2019-00150
• Device Sequence Number: 13779248
• Product Code: NLH
• UDI-Device Identifier: 10888551013307
• UDI-Public: 10888551013307
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K043513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019

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: 07/24/2020
• Device Model Number: BAR201101
• Device Catalogue Number: BAR201101
• Device Lot Number: 2098242
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1