MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL2¿, 63 CM LENGTH, 8.5 F; INTRODUCER, CATHETER

Model Number	407455
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation procedure, difficulty was noted during transseptal puncture.The device was then attempted to be removed and the procedure cancelled, but the sheath was unable to be removed from the access site.After removing the sheath, in an unknown manner, it was observed to be separated with the braiding unwound.
Additional Manufacturer Narrative
The reported event was for transseptal puncture difficulty, sheath removal difficulty and a severed sheath shaft.The results of the investigation are inconclusive since the device was not returned for analysis; however, one image was submitted for evaluation.The image appeared to show the sheath tubing had been torn and separated but was still connected via braid wires.The soft gray tip appeared to be torn and the sheath tubing appeared to have an egg shell like appearance.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The damage is consistent with the product being stored outside the shelf box and exposed to light.The product instructions for use (ifu), warns that the product should be stored in a cool, dark, dry place.
Event or Problem Description
The device was removed from the patient by pulling on the unraveled braiding coil.No additional intervention was required and the procedure was cancelled.

• Brand Name: SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL2¿, 63 CM LENGTH, 8.5 F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8181504
• Report Number: 3005334138-2018-00508
• Device Sequence Number: 1695813
• Product Code: DYB
• UDI-Device Identifier: 05414734205795
• UDI-Public: 05414734205795
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K052644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 407455
• Device Lot Number: 5274842
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 12/26/2018
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other