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

Catalog Number	1001741S
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for evaluation.It was reported that an unknown stent delivery system was advanced down on the whisper guide wire and the stent was deployed with the allstar guide wire behind the stent to protect the pla.It should be noted that the allstar instructions for use (ifu) states: consider that if a secondary wire is placed in a bifurcation branch, this wire may need to be retracted prior to stent deployment because there is additional risk that the secondary wire may become entrapped between the vessel wall and the stent.The investigation determined the reported difficulty appears to be related to an ifu deviation.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the right coronary artery (rca).An allstar guide wire was advanced down the rca into the posterior lateral artery (pla) and a whisper guide wire into the posterior descending coronary artery.An unknown stent delivery system was advanced down on the whisper guide wire and the stent was deployed at 16 atmospheres with the allstar guide wire behind the stent to protect the pla.Both guide wires were pulled back and it was noticed that one of the wires broke (separated).The physician was unable to determine which wire separated; however, a piece of the wire was left inside the patient anatomy.The patient had other issues with coronary artery disease and the physician didn't want to leave the wire inside the patient so the patient was sent to surgery.The surgeon was able to remove the wire piece from behind the stent and the patient went home feeling fine.No additional information was provided.

• Brand Name: ACS HI-TORQUE ALLSTAR GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6589748
• Report Number: 2024168-2017-04463
• Device Sequence Number: 1148561
• Product Code: DQX
• UDI-Device Identifier: 08717648013829
• UDI-Public: (01)08717648013829
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K060449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2017

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 Catalogue Number: 1001741S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2017
• Initial Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention