MAUDE Adverse Event Report: ABBOTT VASCULAR HT BALANCE HEAVYWEIGHT HC; GUIDE WIRE

Catalog Number	1000462HJ
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2019
Type of Reportable Event	Serious Injury
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 investigation.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 the procedure was to treat a right coronary artery.A hi-torque balance heavyweight hydro guide wire was able to be advanced passed a previously implanted stent from 8 years ago, however, when the guide wire was pulled back for removal it felt stuck (believed to be stuck within stent struts).The guide wire was then pulled back once more and it broke in two pieces and was noted as stretched.The separated guide wire piece was retrieved via snare.There was no adverse patient sequela reported.
Additional Manufacturer Narrative
A visual inspection was performed, and the reported separation and stretched coils were confirmed.The reported entrapment of the device was unable to be replicated in a testing environment as it was based on operational circumstances.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.The investigation determined the reported difficulties appear to be related to operational circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HT BALANCE HEAVYWEIGHT HC
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9286574
• Report Number: 2024168-2019-13276
• Device Sequence Number: 11353493
• Product Code: DQX
• UDI-Device Identifier: 08717648015496
• UDI-Public: 08717648015496
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2020

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 Expiration Date: 05/31/2020
• Device Catalogue Number: 1000462HJ
• Device Lot Number: 8060871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2019
• Initial Date Received by Manufacturer: 10/15/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 01/02/2020
• 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