MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0, 81 CM LENGTH, 8.5F; INTRODUCER, CATHETER

Model Number 407452

Device Problems Fracture (1260); Difficult to Insert (1316); Material Separation (1562)

Patient Problems Stroke/CVA (1770); Foreign Body Embolism (4439)

Event Date 03/31/2021

Event Type  Injury  

Manufacturer Narrative

One 8.5f swartz braided introducer sheath was received for evaluation.The reported event of sheath fracture and detachment was confirmed.The soft gray tip and sheath tubing had been fractured into pieces and the tip marker exposed.In addition, inspection of the device identified degradation of shaft material.The damage is consistent with the product being stored outside of the shelf box and exposed to light.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The product instructions for use (ifu) artmt100093395 ver.A warns that product should be stored in a cool, dark, dry place.The cause of the degradation is consistent with not following the instructions for use.The cause of the patient stroke and patient insertion difficulties remains unknown.

Event Description

During a ventricular tachycardia procedure, the gray soft tip of the sheath detached in patient and two days later, the patient experienced stroke symptoms.An mri was conducted to initially diagnose the stroke.During the procedure, difficulty was noted when inserting a non-abbott 8.5f catheter into the introducer after mapping and ablation was conducted.Additionally, the 8.5f non-abbott catheter was difficult to fully insert through the sheath and manipulating the catheter in the patient felt abnormal.The physician removed the sheath and catheter together from the patient and upon removal, the gray soft tip of the sheath was noted to have been detached.The remainder of the sheath tip was sheared and hanging at the end of the sheath.No intervention was administered as the gray soft tip pieces had appeared to disintegrate in the patient and all pieces were not accounted for since they could not be visualized due to being opaque.Two days following the procedure the patient experienced stoke symptoms of blurred vision of the left eye, however no intervention was noted to have been conducted.Further information regarding pre anticoagulation and transesophageal echocardiography and post procedure anticoagulation are unknown.It was unknown if the stroke symptoms were related to the shearing of the device.The patient's symptoms have been noted to have been mostly resolved.Prior to the procedure, the introducer was noted to have been stored on a rack outside of its original packaging.

• Brand Name: SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0, 81 CM LENGTH, 8.5F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11749586
• MDR Text Key: 248771487
• Report Number: 3005334138-2021-00235
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734205764
• UDI-Public: 05414734205764
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 407452
• Device Catalogue Number: 407452
• Device Lot Number: 6970231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other