MAUDE Adverse Event Report: ABBOTT VASCULAR 014 ALLSTAR; GUIDE WIRE

Model Number	1001741J
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event is estimated.G9: 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.It was reported that the device is not available for evaluation.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The additional guide wire referenced in b5 is being filed under a separate medwatch report number.(b)(4).
Event or Problem Description
User facility medwatch report received that states: "when pulling back a guidewire thru the outback elite re-entry catheter the wire was severed on two different occasions with two separate wires (abbott.014 allstar wires).Wire fragments were retrieved.Uncertain if malfunction of device or extensive calcification.What was the original intended procedure? able and pta/stent left common iliac artery, attempted pta r iliac artery.What problem did the user have: device failed.".
Additional Manufacturer Narrative
Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.A review of the electronic lot history record (elhr), corrective action tracking system for the web (catsweb) database review and similar incident query for this product was not performed since the lot number was not reported.The investigation determined the reported separation appears to be related to operational circumstances of the procedure.Based on the reported information, it is likely that during retraction through the outback elite, the guide wire encounters resistance.Manipulation against resistance likely resulted in the reported separation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.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.
Additional Manufacturer Narrative
This report is being resubmitted to ensure the enclosed attachment can be easily opened by the fda.

• Brand Name: 014 ALLSTAR
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8967824
• Report Number: 2024168-2019-11526
• Device Sequence Number: 16666158
• Product Code: DQX
• UDI-Device Identifier: 08717648025952
• UDI-Public: 08717648025952
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K972142
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/20/2020

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 Model Number: 1001741J
• Device Catalogue Number: 1001741J
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 10/15/2019; 07/20/2020
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 10/28/2019; 07/20/2020
• 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: OUTBACK ELITE RE-ENTRY CATHETER 80CM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 55