MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

Catalog Number 1011880

Device Problems Difficult or Delayed Positioning (1157); Entrapment of Device (1212); Material Separation (1562); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical devices: guide wire: whisper es, sheath: 6 fr, 7 fr, stent: 3.5 x 12 mm ultimaster.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the patient presented emergently with lower myocardial infarction (mi) and had a percutaneous coronary intervention of the marginal branch artery.The balance middleweight (bmw) guide wire was positioned in the vessel and a non-abbott balloon and drug eluting stent were successfully used.During movement and positioning of the bmw in different vessels, the wire became detached and remained in the vessel.Two unsuccessful attempts to remove the guide wire were made; the procedure was ended.On (b)(6) 2018 another attempt was made to retrieve the detached guide wire fragment.Intravascular ultrasound (ivus) confirmed the guide wire fragment mid section was under the stent strut.A vascular loop was used successfully to snare the wire fragment; however, the fragment slipped out in the left coronary artery.A larger size loop was used in the left main after exchanging to a larger sheath size.The fragment migrated from the left main to the ascending aorta, then to the descending aorta.Attempts to catch the guide wire fragment in those locations were unsuccessful.It was noted that only a 5 mm section of the guide wire fragment was visible in x-ray images due to low angiography resolution.Follow-up ivus to trace the path of the guide wire fragment showed no vessel irregularities.The fragment was captured in the abdominal aorta and removed from the anatomy.There was no reported adverse patient sequela.The patient was discharged (b)(6) 2018.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was returned for analysis.The reported stretched and the reported detachment were confirmed.The reported difficulty to position and entrapment could not be replicated in a testing environment as they were based on operational circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during movement and positioning interaction with the anatomy/other devices resulted in the reported difficulty to position.Manipulation of the device resulted in the noted stretched coils and ultimately resulted in the reported/noted detachment.Interaction with the deployed stent resulted in the reported entrapment.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 7995403
• MDR Text Key: 124702371
• Report Number: 2024168-2018-08104
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K103101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 1011880
• Device Lot Number: 8030561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2018
• Initial Date FDA Received: 10/23/2018
• Supplement Dates Manufacturer Received: 11/01/2018
• Supplement Dates FDA Received: 11/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2018
• 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: 44 YR