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

Model Number C12058

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/28/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of the investigation concluded that the tip coil of the radiopaque tip had been fractured and separated from the weld joint; the corewire had also been fractured.The tip coil had been bent and stretched.The distal section of the fractured corewire remained attached at the tip coil distal tip and was bent at the location of the fracture.The combined length of the two corewire sections indicated there was no missing material from the distal tip assembly.The hydrophilic coated distal tube and shaft had been kinked and bent.Information from the field stated that the tip was bent backwards in the ostium and broke off.The device met specifications prior to leaving sjm manufacturing facilities as supported by a review of the device history record.There was no evidence found to suggest the incident was due to an intrinsic defect in the returned device.The cause of guidewire damage is consistent with forcible contact during use.The pressurewire 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 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.

Event Description

The tip of the pressurewire aeris was shaped by the physician before insertion.During insertion, the tip bent backwards in the ostium, the physician continued to push and the tip broke off.The tip was successfully snared.Ffr measurement was abandoned and the pci procedure was successfully completed.The patient was stable.

• Brand Name: PRESSURE WIRE AERIS G8
• Type of Device: TRANSDUCER, PRESSURE,CATHETER TIP
• 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
• Manufacturer (Section G): 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
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 6031217
• MDR Text Key: 57492247
• Report Number: 3008452825-2016-00139
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: C12058
• Device Catalogue Number: C12058
• Device Lot Number: 5582666
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2016
• 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): Required Intervention