MAUDE Adverse Event Report: ABBOTT VASCULAR HT BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

Model Number	1011880
Medical Device Problem Codes	Break (1069); Stretched (1601)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that upon opening the package of the balance middleweight (bmw) elite guide wire, the tip coils of the guide wire were separated but the core was not detached.The device was not used and there was no patient involvement.Another same size bmw guide wire was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned guide wire.The reported stretched coils were confirmed.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.The investigation determined the reported stretched coils appear to be related to circumstances of the procedure.Based on the reported information, it is likely that the technique used during removal of the guide wire from the dispenser coils, the coils were inadvertently stretched and misaligned.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: code 1069 removed.
Event or Problem Description
Subsequent to the initially filed report, the following information was received: the tip coils of the balance middleweight elite guide wire were actually stretched and not separated.No additional information was provided.

• Brand Name: HT BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9396078
• Report Number: 2024168-2019-14012
• Device Sequence Number: 14178960
• Product Code: DQX
• UDI-Device Identifier: 08717648144783
• UDI-Public: 08717648144783
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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: 04/30/2021
• Device Model Number: 1011880
• Device Catalogue Number: 1011880
• Device Lot Number: 9050761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1