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

Model Number 1005203

Device Problems Break (1069); Difficult to Insert (1316); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for analysis.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 identified no other incidents.The product risk assessment identifies this as a foreseeable event.The investigation was unable to determine a cause for the reported stretched coil, break and difficult to insert events.It may be possible that during insertion of the wire into the bdc the coils were stretched, possibly due to a break, and that created the resistance making it difficult to insert.This could not be confirmed because the guide wire was not returned.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 after inserting into the balloon dilatation catheter (bdc) with resistance noted, the tip of the spartacore guide wire was shredded/coils were exposed [possible breakage] and unable to be used.The guide wire was immediately removed.It was confirmed that nothing remained in the patient.A new guide wire was used to complete the procedure.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HI-TORQUE SPARTACORE 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 # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10490567
• MDR Text Key: 213646216
• Report Number: 2024168-2020-07370
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08717648014031
• UDI-Public: 08717648014031
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963702
• 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: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 1005203
• Device Catalogue Number: 1005203
• Device Lot Number: 9121261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2019
• 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