MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA PRESSURE WIRE AERIS G8; TRANSDUCER, PRESSURE,CATHETER TIP

Model Number C12058

Device Problems Fracture (1260); Material Fragmentation (1261); Migration or Expulsion of Device (1395)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/10/2017

Event Type  Injury  

Event Description

The patient presented with angina and angiography showed a 50% stenosed lesion.While obtaining a reading in the first obtuse marginal coronary artery, the pressure wire aeris tip was sheared off.The separated tip migrated to the left main and then into a lumbar branch.The tip was successfully snared after three hours, but the snaring resulted in a dissection in the lumbar branch.The dissection was resolved with balloon angioplasty.It was reported that while this issue caused a significant delay, the delay did not result in a health impact.The planned procedure was postponed for completion at a different date.There were no adverse patient sequelae.

Manufacturer Narrative

Product evaluation: the reported event of the guidewire fracture was confirmed.The results of the investigation concluded that the tip coil of the radiopaque tip had been fractured and separated from the distal end sensor element (jacket); the fractured tip coil was returned loose.The corewire had been subsequently fractured.The distal portion of the fractured corewire was attached to the tip coil distal tip.Additional investigation revealed that the wire was exposed to excessive torque and manipulation and there is evidence of welding on the proximal joint between the coil and the corewire.Torquing or excessive manipulation of the guidewire in a sharp bend, against resistance, or repeated attempts to cross a total vessel occlusion may damage and/or fracture the pressurewire, which is inconsistent with the instructions for use (ifu).The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the guidewire damage is consistent with forcible contact during use.The pressurewire aeris instructions for use (ifu) states that excessive manipulation of the pressurewire when the sensor element or pressurewire tip is located in sharp bend may cause damage or tip fracture.The pressurewire aeris instructions for use (ifu) states that torquing the pressurewire against resistance or repeated attempts to cross a total vessel occlusion may cause damage and/or fracture, which may lead to a portion of pressurewire separating from the tip.The pressurewire aeris instructions for use (ifu) states that the user should advance or withdraw the pressurewire slowly and never push, withdraw or torque the pressurewire if it meets resistance.The pressurewire aeris instructions for use (ifu) states that the user should not torque the pressurewire without observing corresponding movement of the tip; otherwise vessel/ventricle trauma may occur.

Manufacturer Narrative

Medwatch number: (b)(4).

Event Description

The patient presented with angina and angiography showed a 50% stenosed lesion.The patient was undergoing coronary intervention (ffr) of the obtuse marginal vessel of the left circumflex coronary artery using a pressurewire aeris.During advancement and upon usual negotiation of the wire through distal curvature to attempt to obtain a reading in the first obtuse marginal coronary artery, the wire became unresponsive.The wire was carefully counter-rotated to remove, but it would not respond normally.The pressurewire aeris tip was sheared off and became loose in the artery.Two soft wires were looped around the wire fragment, which was atraumatically brought into the left main.While preparing to snare, the separated tip migrated to the abdominal aorta and appeared to lodge in the lumbar artery.Retrieval was attempted, but the tip migrated more distally into the lumbar artery.The snaring resulted in dissection in the lumbar artery with symptoms requiring ptca to restore blood flow.The dissection was resolved with balloon angioplasty.Three wires were then passed distal to the wire, and the tip was engaged and able to be retrieved into the guide after three hours.The entire wire-device-guide unit was pulled out under fluoroscopy with confirmed full retrieval of the wire.It was reported that while this issue caused a significant delay, the delay did not result in a health impact.The planned procedure was postponed for completion at a different date.There were no adverse patient sequelae.

• Brand Name: PRESSURE WIRE AERIS G8
• Type of Device: TRANSDUCER, PRESSURE,CATHETER TIP
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 6734250
• MDR Text Key: 80747282
• Report Number: 3008452825-2017-00163
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2017

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: 10/31/2018
• Device Model Number: C12058
• Device Catalogue Number: C12058
• Device Lot Number: 5747399
• Other Device ID Number: 05414734055772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2017
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: 07/24/2017; 10/11/2017
• Supplement Dates FDA Received: 08/17/2017; 10/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 101