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

Catalog Number UNK HT SUPRA CORE 35

Device Problems Break (1069); Difficult to Insert (1316); Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2022

Event Type  malfunction  

Event Description

It was reported that a general comment was made by the physician that the supracore guide wire tip would become uncoiled (unraveled) during advancement due to calcification.Additionally, it was also noted that the solder point of the guide wire appeared to be too big and when attempted to be loaded could not be inserted with the balloon.The physician also commented that the herculink stent balloon would get stuck with the 6f catheter during removal.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The unique device identifier (udi) is unknown because the part number and lot number were not provided.The device was not returned for analysis.A review of the lot history record and similar incident review of the reported lot could not be conducted because the part and lot number was not provided.The investigation determined the reported break appears to be related to circumstances of the procedure as it is likely due to interaction with the calcified anatomy.A conclusive cause for the reported irregular appearance (solder point of the guide wire appeared to be too big) resulting in the reported difficult to insert cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.The herculink referenced in b5 is filed under a separate medwatch report number.Na.

• Brand Name: HI-TORQUE SUPRACORE 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: 15583674
• MDR Text Key: 303057302
• Report Number: 2024168-2022-10526
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HT SUPRA CORE 35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2022
• 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