MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE COMMAND 18 GUIDE WIRE

Model Number 1013753

Device Problems Off-Label Use (1494); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2020

Event Type  malfunction  

Manufacturer Narrative

Product performance engineering reviewed the reported information; however, the device was not returned for evaluation.A review of the electronic lot history record and similar incident query for this product was not performed since the lot number was not reported and the device was not returned for analysis.It should be noted that per electronic instructions for use (ifu), high torque command 18 guide wire for pta: this hi-torque guide wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal angioplasty (pta), in arteries such as the femoral, popliteal and infra-popliteal arteries.This guide wire may also be used with compatible stent devices during therapeutic procedures.The guide wire may also be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.Although it was reported that the physician used the device in the wrong the anatomy, the reported violation of the ifu did not caused or contribute to the reported complaint.The investigation determined the reported difficulty to remove appear to be related to operational circumstances of the procedure.It is likely that during the procedure the delivery device or guide wire became damaged due to manipulation resulting in the difficulty to remove.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to place a cardiomems sensor using a hitorque command 18 guide wire.The guide wire was inserted into the lower left lobe of the pulmonary artery.The sensor was deployed without incident, however; resistance was felt when removing the guide wire out of the delivery catheter.The delivery catheter and guide wire were removed as a single unit.There were no adverse patient effects and no clinically significant delay in the procedure.

• Brand Name: HI-TORQUE COMMAND 18 GUIDE WIRE
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005737652; road no.2 km 58.0 cruce dávila; barceloneta PR 00617
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10358257
• MDR Text Key: 202055325
• Report Number: 2024168-2020-06428
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08717648211980
• UDI-Public: 08717648211980
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1013753
• Device Catalogue Number: 1013753
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 70 YR
• Patient Weight: 122