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

Catalog Number	1001309S
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	08/24/2018
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 returned for analysis.The reported detachment was able to be confirmed.The reported difficult to remove was unable to be replicated in a testing environment as it was based on operational circumstances.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.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 similar incidents from this lot.It should be noted that the hi-torque guide wires instructions for use states: all hi-torque guide wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (ptca) and percutaneous transluminal angioplasty (pta).The investigation determined the reported difficulties appear to be related to deviation of the instruction for use and subsequent circumstances as the lead of the pacemaker was advanced over the guide wire (against the instruction for use) and the pace maker was placed in the coronary sinus.During removal of the guide wire interaction with the lead of the pacemaker resulted in the reported difficult to remove.It should be noted that the hi-torque guide wires instructions for use states: do not: push, auger, withdraw, or torque a guide wire that meets resistance.Excessive force applied resulting in the reported/noted device damages (stretched coils, coil/core detachments).There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that the procedure was performed to treat a coronary sinus.A 014 ironman guide wire was advanced to the coronary sinus.The lead of the pacemaker was advanced over the guide wire and the pace maker was placed in the coronary sinus.During removal of the guide wire, the guide wire became stuck with the lead of the pacemaker.Excessive force was applied when the tip of the guide wire broke off [detached].The remainder of the guide wire was simply removed, but the broken tip remained embedded in the coronary sinus, ending the procedure.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ACS HI-TORQUE IRON MAN 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: 7885659
• Report Number: 2024168-2018-07245
• Device Sequence Number: 16771374
• Product Code: DQX
• UDI-Device Identifier: 08717648013645
• UDI-Public: 08717648013645
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2018

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 Expiration Date: 03/31/2020
• Device Catalogue Number: 1001309S
• Device Lot Number: 8041861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 09/18/2018
• 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: Other
• Patient Age: 80 YR