MAUDE Adverse Event Report: BRIVANT LTD HI TORQUE CONNECT GUIDEWIRE

Model Number 901022-09

Device Problems Break (1069); Device Abrasion From Instrument Or Another Object (1387); Peeled/Delaminated (1454); Stretched (1601)

Patient Problems No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)

Event Date 11/23/2015

Event Type  malfunction  

Manufacturer Narrative

Device evaluation is underway, initial investigation based on the lot history records review confirmed that the guidewires were manufactured according to the specification.The required tests and inspections were performed and passed.A follow up report will be provided.Device evaluation underway.

Event Description

It was reported that the procedure was to treat a lesion in the distal femoral artery with mild tortuosity and heavy calcification.At the end of the procedure and during withdrawal, some resistance was noted during removal of an ht connect guide wire.Reportedly it was impossible to remove the guide wire alone,so the guide wire and guide catheter were removed as a single unit from the patient`s anatomy.After removal of the guide wire out of the patient,it was noted that the tip of the wire (coating)was ripped off.The patient is doing well.Additional information was requested.

Manufacturer Narrative

Device evaluation is underway, initial investigation based on the lot history records review confirmed that the guidewires were manufactured according to the specification.The required tests and inspections were performed and passed.Complaint was reported as a ptfe coating issue however on evaluation of the returned device it was confirmed that there was no coating delamination and the complaint was re-classified as coil damage.

Event Description

It was reported that the procedure was to treat a lesion in the distal femoral artery with mild tortuosity and heavy calcification.At the end of the procedure and during withdrawal,some resistance was noted during removal of an ht connect guide wire.Reportedly it was impossible to remove the guide wire alone,so the guide wire and guide catheter were removed as a single unit from the patient`s anatomy.After removal of the guide wire out of the patient,it was noted that the tip of the wire (coating)was ripped off.The patient is doing well.Additional information was requested.

• Brand Name: HI TORQUE CONNECT GUIDEWIRE
• Type of Device: GUIDEWIRE
• Manufacturer (Section D): BRIVANT LTD; parkmore west business park; galway, ; EI
• Manufacturer (Section G): BRIVANT LTD; parkmore west business park; galway, ; EI
• Manufacturer Contact: suzanne foley ; butlersland; new ross, co wexford ; EI ; 51440500
• MDR Report Key: 5317591
• MDR Text Key: 34075614
• Report Number: 3006010712-2015-00023
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: 901022-09
• Device Lot Number: 10473775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2015
• 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): Other