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

Catalog Number	1001780S
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/22/2016
Type of Reportable Event	Malfunction
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 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 of the reported lot did not indicate a lot specific quality issue.It should be noted the hi torque guide wire instructions for use (preparation for use section) states: prior to the interventional procedure, examine carefully all equipment to be used, including the interventional device for defects.Do not use any defective equipment.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 an unspecified coronary artery.During prep, visual and tactile inspection were performed on a 014 balance middleweight (bmw) 3cm guide wire and a little step was noted 30 cm from the distal tip.The bmw device was advanced into the patient anatomy.When advancing a non-abbott stent delivery system (sds) over the bmw, the sds was unable to be advanced past the step on the bmw and was also difficult to retract from that step.All devices were removed from the anatomy as a single unit.The bmw guide wire was replaced with a new unspecified guide wire to complete the procedure.There were no adverse patient effects and no occurrence of a clinically significant delay.No additional information was provided.

• Brand Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE
• Common Device Name: GUIDE WIRES
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6268423
• Report Number: 2024168-2017-00606
• Device Sequence Number: 18888182
• Product Code: DQX
• UDI-Device Identifier: 08717648013836
• UDI-Public: (01)08717648013836(17)181031(10)6110771
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K101116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/20/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 1001780S
• Device Lot Number: 6110771
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2017
• Initial Report FDA Received Date: 01/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STENT: ONYX