MAUDE Adverse Event Report: ST. JUDE MEDICAL AGILIS NXT STEERABLE INTRODUCER DUAL-REACH 71 CM SHEATH, MEDIUM CURL, 8.5 F; INTRODUCER, CATHETER

Model Number 408310

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference: 3005334138-2020-00219.During a redo pulmonary vein isolation procedure, an entanglement occurred.Two transseptal punctures were performed with a sheath without any issues.The second puncture with the agilis appeared successful as there was tenting of the septum.The needle went to the left atrium, along with the wire and obturator.However, when pushing the agilis sheath it took more force than expected.The hd grid was introduced without any issue, but the sheath and catheter were not functioning as expected.After pulling back to the right atrium and using fluoroscopy, the catheter and sheath were noted to be entangled.Upon removing the entangled catheter and sheath combination, there was difficulty removing from the groin.No further intervention was needed to remove the devices, only small movements and some force, and the devices were removed.There was no bleeding of the groin noted.Damage was noted to both devices, however the sheath was not replaced to continue.The hd grid was replaced, and the procedure was completed without any adverse consequences for the patient.

Manufacturer Narrative

One agilis¿ nxt steerable introducer dual-reach¿ 71 cm sheath, medium curl, 8.5 f was received for investigation.The sheath had been bent in multiple locations and the sheath side hole had been stretched.No anomalies were noted when a dilator from current inventory was advanced through the returned sheath.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the bends in the sheath and stretched sheath side hole is consistent with damage during use.The cause of the catheter entrapment and withdrawal difficulty remains unknown.

• Brand Name: AGILIS NXT STEERABLE INTRODUCER DUAL-REACH 71 CM SHEATH, MEDIUM CURL, 8.5 F
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 10155004
• MDR Text Key: 196160621
• Report Number: 3008452825-2020-00269
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 05414734206105
• UDI-Public: 05414734206105
• Combination Product (y/n): N
• PMA/PMN Number: K061363
• 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: 08/06/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 408310
• Device Catalogue Number: 408310
• Device Lot Number: 7416841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/15/2020
• Supplement Dates Manufacturer Received: 07/15/2020
• Supplement Dates FDA Received: 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿