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)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product evaluation: the results of the investigation concluded that the tip coil of the radiopaque tip and the corewire had been fractured and separated from the weld joint.The distal section of the fractured corewire remained attached at the tip coil distal tip and the proximal section had been attached to the jacket.The combined length of the corewire sections and the tip coil length indicated there was no missing material from the distal tip assembly.The tip coil and the shaft had been bent.Sjm also received information from the field stating that the guidewire was used in conjunction with a 4.2f, jl3.5 cag catheter, which is inconsistent with the instruction for use (ifu), which states, ¿use pressurewire in conjunction with 6f (2mm diameter) guiding catheter.¿ 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.Although the exact cause of the reported insertion difficulty remains unknown, the guidewire damage is consistent with the reported insertion difficulty.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 torqueing 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

There was resistance felt when the pressurewire aeris was advanced to the equalization point inside of a 4.2f, jl3.5 cag catheter.The pressurewire did not come out of the end of the catheter.The device was pulled and pushed, and there was resistance that felt like something had split.The distal tip of the pressurewire was found fractured near the left main trunk (lmt).An attempt was made to withdraw the breakage with a snare catheter, but it had advanced to the distal left circumflex artery (lcx).The snare catheter was withdrawn and three pci guidewires were inserted and manipulated to retrieve the tip.The ffr procedure was aborted.The physician suspected that the pressurewire was advanced into a side hole of the catheter and became fractured by resistance.

• 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: 5924773
• MDR Text Key: 53816560
• Report Number: 3008452825-2016-00120
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: C12058
• Device Catalogue Number: C12058
• Device Lot Number: 5534642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2016
• 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