MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE WHISPER MS GUIDE WIRE; GUIDE WIRES

Catalog Number 1005357HJ

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/24/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

User facility medwatch report (mw5071343) received that states the following: during a cardiac electrophysiology procedure, the physician was using the whisper guide wire to guide a lead into place.He felt resistance when he went to remove the guide wire, and had trouble removing it despite moving all the other components he was working with.At one point, the resistance released, and he noticed there was a retained portion of the wire.The wire did not move during the rest of the procedure, and he elected no further intervention to remove the portion of the wire.Additional information was reported: the patient underwent a procedure to place a pacemaker lead for a bi-ventricular implantable cardiac defibrillator (icd).Resistance was noted during advancement of the guide wire and during advancement of other devices with the guide wire.Difficulty was noted accessing the branch and advancing the outer carotid positioning sheath (cps) and inner non-abbott sheath.There seemed to be a long portion of the guide wire in the anatomy and it was thought that the guide wire wrapped around itself.The physician pulled on the guide wire to remove and the guide wire separated.It was thought that the guide wire had possibly caught between the outer sheath and the inner sheath, but this could not be confirmed.The guide wire remained in a coronary vein, as there was no way to snare it.No additional intervention was performed to remove the separated segment.No additional information was provided.

Manufacturer Narrative

(b)(4).Concomitant medical products: medtronic inner catheter, quadra allure mp rf pacemaker, tendril sts pacing lead, quartet lv lead.Medtronic inner catheter, quadra allure mp rf pacemaker, tendril sts pacing lead, quartet lv lead the device was not returned for evaluation.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 did not indicate a lot specific quality issue.The whisper instructions for use (ifu)states that all hi-torque guide wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (ptca) and percutaneous transluminal angioplasty (pta).Additionally, the ifu instructs not to push, auger, withdraw or torque a guide wire that meets resistance.It is undetermined if the deviation to the ifu contributed to the reported difficulties.The investigation was unable to determine a conclusive cause for the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

• Brand Name: HI-TORQUE WHISPER MS GUIDE WIRE
• Type of Device: GUIDE WIRES
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): BARCELONETA, PUERTO RICO REG# 3005737652; 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: 6813576
• MDR Text Key: 83421553
• Report Number: 2024168-2017-06875
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 1005357HJ
• Device Lot Number: 6072671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• 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
• Treatment: OUTER CAROTID POSITIONING SHEATHINNER SHEATH
• Patient Outcome(s): Other
• Patient Age: 98 YR