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

Catalog Number 1009664

Device Problems Difficult to Insert (1316); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the crmd (cardiac rhythm management division) low voltage lead was just about successfully implanted when the physician noted that the balance middleweight (bmw) universal ii guide wire was stuck in the lead.The physician believes it could be due to a kink in the wire because there was also difficulty getting the guide wire into the lead.The guide wire could not be removed from the lead despite using force, so they were removed together and a new lead and a new guide wire were used to continue the procedure.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Correction: it was initially reported that the device would be returned for analysis.Subsequent information revealed that the device was discarded and is not available for evaluation.Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.It should be noted that the hi-torque guide wires for ptca, pta, and stents, instructions for use (ifu), states: if resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed.In this case, the reported ifu violation pulled with force does not appear to have caused or contributed to the reported difficulty to insert or wire kink.A review of the lot history record, corrective action tracking system for the web (catsweb) database review and similar incident query for this product was not performed since the lot number was not reported and the product and product packaging were not returned for analysis.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.Based on the reported information, it is likely that manipulation during advancement through the cmrd low voltage lead quartet, the guide wire kinked causing the guide wire to get stuck, resulting on the difficulty to insert or advance the wire and the difficulty to remove during retraction.There is no indication of a product quality issue with respect to design, manufacture or labeling.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8664180
• MDR Text Key: 146845010
• Report Number: 2024168-2019-04329
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K072460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1009664
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OTHER: CMRD LOW VOLTAGE LEAD QUARTET; OTHER: CMRD LOW VOLTAGE LEAD QUARTET