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

Catalog Number	1009661
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2019
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 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 identified no other similar incidents reported from this lot.The investigation determined the reported difficulty to remove appear to be related to operational circumstances of the procedure.Based on the reported information, the guide wire encountered resistance with the severely calcified anatomy resulting on the reported difficult to remove and stretched guide wire coils.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.
Event or Problem Description
It was reported that this was a percutaneous coronary intervention treating a left anterior descending (lad), severely calcified lesion.There was no tortuosity.A balance middleweight guide wire (bmw) was successfully placed and a 3.0x28mm xience sierra stent was successfully implanted.During bmw removal, difficulty was encountered and the wire coils had stretched.There was no observed interaction between the stent and bmw and the difficulty removing the bmw was deemed due to anatomy.The bmw was removed from the patients anatomy without further issues.There were no adverse patient effects and there was no clinically significant delay.No additional information was provided regarding this issue.

• Brand Name: HT BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8823738
• Report Number: 2024168-2019-10324
• Device Sequence Number: 2541003
• Product Code: DQX
• UDI-Device Identifier: 08717648014345
• UDI-Public: 08717648014345
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K101011
• 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
• Report Date (Section B): 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 1009661
• Device Lot Number: 9041071
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 07/24/2019
• 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: 3.0X28MM XIENCE SIERRA STENT; 3.0X28MM XIENCE SIERRA STENT
• Patient Age: 73 YR
• Patient Weight: 103