MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE PILOT GUIDE WIRE

Catalog Number 1010480-H

Device Problems Failure to Advance (2524); Device Operates Differently Than Expected (2913)

Patient Problem Perforation (2001)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 from this lot.It should be noted that the reported patient effect(s) of perforation is listed in the hi-torque guide wires instructions for use (ifu) as a known patient effect of coronary stenting procedures.The investigation determined the reported failure to advance appears to be related to circumstances of the procedure as it is likely that as the guide wire was advanced resistance was met with the moderately calcified anatomy resulting in the reported failure to advance.A conclusive cause for the reported perforation, and the relationship to the product, if any, cannot be determined.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 a balance middle weight (bmw) guide wire was placed in the left anterior descending (lad).Using a buddy wire technique, a hi-torque pilot guide wire was advanced to the bmw without issue, however, the device failed to cross the moderately calcified lesion as a perforation occurred at the ht pilot lad site.The device was removed without reported issue and balloon angioplasty was performed for 2 minutes as treatment.The perforation was resolved.No additional information was provided.

• Brand Name: HI-TORQUE PILOT GUIDE WIRE
• Type of Device: GUIDE WIRE
• 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: 7507724
• MDR Text Key: 108028812
• Report Number: 2024168-2018-03498
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08717648073854
• UDI-Public: 08717648073854
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060449
• 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
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 1010480-H
• Device Lot Number: 8011571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• 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: BALANCE MIDDLE WEIGHT (BMW) GUIDE WIRE
• Patient Outcome(s): Required Intervention
• Patient Weight: 95