MAUDE Adverse Event Report: AV-TEMECULA-CT ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

Device Problems Difficult to Remove (1528); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was performed to treat a lesion in the marginal coronary artery with moderate calcification.A dragonfly optical coherence tomography (oct) catheter was advanced and removed over an unk abbott guide wire with no reported problems.The oct was successfully re-advanced over the guide wire; however, on removal, the oct was reported to spin and as a result met resistance and coiled up with the guide wire.The oct could not be separated from the guide wire and both devices were therefore removed as a single unit.The coils of the guide wire appear stretched.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Visual inspection was performed on the returned guide wire.The stretched coils were confirmed.The difficulty removing was not tested due to the condition of the returned guide wire.The lot history record for this product could not be reviewed and a similar incident query could not be performed because the part and lot numbers were not reported and the packaging was not returned.The investigation concluded that the reported difficulties were due to case circumstances.It is likely that during the second advancement, interaction occurred with the dragonfly optis imaging catheter and the guide wire causing the imaging catheter to physically wrap around the guide wire resulting in the reported difficulty to remove and stretched tip coils noted on the returned guide wire.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8179692
• MDR Text Key: 130986032
• Report Number: 2024168-2018-09862
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K013833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/13/2018
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 12/20/2018
• Supplement Dates FDA Received: 12/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OTHER: DRAGONFLY OCT CATHETER
• Patient Age: 74 YR
• Patient Weight: 61