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

Catalog Number	BAR201101
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2019
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 procedure with an ep diagnostic catheter dynamic xt steerable decapolar large and the deflection became stuck.During the procedure, the curve of the catheter was stuck in a deflected position with full tension on the curved tip and could not be relaxed.The device was changed to a boston scientific dyna.The procedure was completed and 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 procedure with an ep diagnostic catheter dynamic xt steerable decapolar large and the deflection became stuck.The returned device was examined and subjected to full function testing, evaluating the deflection and curve capabilities of the device.The catheter was observed to deflect and return to its neutral position.There was no indication the distal tip of the catheter is stuck or sticking.It is steerable.There are indications the product was removed from its packaging and handled.Though the catheter was observed with a bend in its shaft, it passed all functional tests as it met the expected deflection and curvature for this model.The reported issue is not confirmed.The device history record was reviewed, and the device had met all visual and functional criteria prior to being distributed to the customer.In addition, a manufacturing record evaluation was conducted for lot# 2096285 and no non-conformances were identified.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: 9412642
• Report Number: 2134070-2019-00147
• Device Sequence Number: 1834631
• 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): 11/11/2019

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: 06/28/2020
• Device Catalogue Number: BAR201101
• Device Lot Number: 2096285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1