MAUDE Adverse Event Report: AV-TEMECULA-CT ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

Catalog Number	1000462HJ
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2017
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.The device was not returned for analysis.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.The investigation determined the reported failure to advance, difficult to position and separation appear to be related to the patient anatomical conditions.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 mildly tortuous coronary artery.A balance heavyweight (bhw) hydro guide wire was selected for the procedure.The bhw hydro guide wire was advanced toward the lesion; met resistance near the shoulder and would not advance any further.The physician then tried to advance an unspecified catheter over the guide wire and also met resistance.The catheter and the bhw guide wire were removed from the anatomy as one unit.Once the guide wire was removed from the anatomy, it was discovered that the tip of the guide wire had separated and was still in the anatomy.A snare was used to retrieve the separated tip from the anatomy.There was no reported adverse patient sequela.The physician commented that the tip separation was due to the patient's anatomy and the radial access site.No additional information was provided.

• Brand Name: ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6414775
• Report Number: 2024168-2017-02263
• Device Sequence Number: 1002021
• Product Code: DQX
• UDI-Device Identifier: 08717648015496
• UDI-Public: (01)08717648015496
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K013833
• 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): 03/17/2017

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: 1000462HJ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2017
• Initial Report FDA Received Date: 03/17/2017
• 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