MAUDE Adverse Event Report: ABBOTT VASCULAR HT COMMAND 18; GUIDE WIRE

Model Number	1013753
Medical Device Problem Codes	Product Quality Problem (1506); Difficult to Remove (1528); Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to place a cardiomems sensor using a hitorque command lt guide wire.As the sensor was being advanced over the guide wire, it was noted that it could not advance past the right ventricular (rv).The guide wire was noted as feeling gritty or sticky.Both the sensor and guide wire were removed together.Two sections of coating were missing that were approximately 5cm long from the wire.It was noted that the coating would get stuck while retracting the wire out of the sensor delivery catheter.It is unknown if any of the guide wire coating was left in the patient.It was decided to use a steelcore guide wire to successfully complete the procedure.There was no adverse patient sequela reported.Although a 30 minute delay was added to procedure time, the physician did not deem it clinically significant.No additional information was provided.
Additional Manufacturer Narrative
Visual, dimensional and functional inspections were performed on the returned guide wire.The reported irregular texture and torn polymer were confirmed.The reported difficulty to advance and difficulty to remove were unable to be confirmed due to the returned condition of the guide wire.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Based on the review of similar incidents there is no indication of a lot specific product quality issue.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/noted difficulties appear to be related to operational circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HT COMMAND 18
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10319877
• Report Number: 2024168-2020-06178
• Device Sequence Number: 16902224
• Product Code: DQX
• UDI-Device Identifier: 08717648211980
• UDI-Public: 08717648211980
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K152404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 1013753
• Device Catalogue Number: 1013753
• Device Lot Number: 0031761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARDIOMEMS; CARDIOMEMS
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR