MAUDE Adverse Event Report: ABBOTT VASCULAR HI TORQUE SPORTACORE GUIDE WIRE

Catalog Number	1005203
Medical Device Problem Codes	Peeled/Delaminated (1454); Off-Label Use (1494); Difficult to Advance (2920)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2019001.The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that outside the anatomy an atherectomy catheter was being advanced over a hi-torque spartacore 14 guide wire; however, resistance was felt and it was noted that the polymer coating was peeling.The guide wire was removed from the atherectomy catheter.The atherectomy catheter was flushed and used successfully with a new hi-torque spartacore 14 guide wire.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.Return of the guide wire may have further aided the 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 identified no other similar incidents reported from this lot.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.It should be noted that instructions for use guide wire hi-torque guide wires, ce/fda 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).In this case, the reported use of an atherectomy device may have caused the reported peeling and difficulty to position as it is likely that the sharp edge of the atherectomy device scraped the teflon coating resulting in the peeling and difficulty to advance.The investigation determined the reported peeling and difficulty to advance/position appears to be related to operational circumstances of the procedure.It is likely that inadvertent manipulation and/or handling of the guide wire during advancement through the atherectomy device, the guide wire became dragged or scraped against the sharp end of the atherectomy device causing the peeling and difficulty to advance/position.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HI TORQUE SPORTACORE GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9263347
• Report Number: 2024168-2019-13106
• Device Sequence Number: 11695320
• Product Code: DQX
• UDI-Device Identifier: 08717648014031
• UDI-Public: 08717648014031
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K963702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2019

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: 06/30/2020
• Device Catalogue Number: 1005203
• Device Lot Number: 8071761
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 12/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1