MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, LAMP 45, 63 CM LENGTH, 8.5F; INTRODUCER, CATHETER

Model Number 407362

Device Problem Entrapment of Device (1212)

Patient Problem Embolism (1829)

Event Date 07/23/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.Further information regarding the event was requested but not received.

Event Description

Related manufacturer reference: 3005334138-2020-00323.During a premature ventricular contraction ablation procedure, an entanglement and subsequent cancellation occurred.Two femoral introducers were placed into the femoral vein.Following the coronary sinus and right ventricle mapping, a transseptal puncture was performed, exchanging the introducer and removing the tacticath catheter.When the sheath was in the superior vena cava, the hd grid was inserted into the introducer to complete the previous map made in the right ventricle.When the hd grid was attempted to be removed, it was entangled.The hd grid was able to be removed with force, however damage was noted too the device.It is unknown what the hd grid was entangled on causing the removal difficulty.When the sheath was attempted to be removed, it also became entangled and broke at the most proximal part, leaving most of the sheath length left in the patient.The detached introducer component could not be removed.The procedure was unable to be completed and the patient was followed.The detached component was removed successfully by a vascular physician using a subclavian approach.The patient recovered and there were no adverse patient consequences.

Manufacturer Narrative

One 8.5f swartz braided introducer hemostasis sheath was received for evaluation.The results of the investigation concluded that the sheath tubing had been fractured and separated into two sections, the distal section of the detached tubing was not returned.The sheath tubing had also been kinked and had been scraped/gouged and stretched at multiple locations.Functional testing could not be performed due to the aforementioned damage to the sheath; however, the damage is consistent with the reported catheter withdrawal difficulty.The sheath hemostasis cap inside diameter measurement was within specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the received condition of the device and the information provided, the cause of the catheter withdrawal difficulty and subsequent sheath damage remains unknown.

• Brand Name: SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, LAMP 45, 63 CM LENGTH, 8.5F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10345864
• MDR Text Key: 201429751
• Report Number: 3005334138-2020-00322
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734205573
• UDI-Public: 05414734205573
• Combination Product (y/n): N
• PMA/PMN Number: K052644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 407362
• Device Catalogue Number: 407362
• Device Lot Number: 7380714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/23/2020
• Initial Date FDA Received: 07/30/2020
• Supplement Dates Manufacturer Received: 10/08/2020
• Supplement Dates FDA Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVISOR HD GRID MAPPING CATHETER, SENSOR ENABLED
• Patient Outcome(s): Required Intervention