MAUDE Adverse Event Report: AV-TEMECULA-CT ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

Catalog Number	1000462H
Medical Device Problem Codes	Material Separation (1562); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded that based on the information provided and the root cause determination obtained after the initial reporting; it appears that the heavily tortuous and concentric anatomy as well as multiple aggressive attempts to advance the wire may have contributed to the reported detachment.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported that during a procedure of the heavily tortuous, concentric, distal right coronary artery (rca) the balance heavyweight (bhw) guide wire was advanced with anatomical resistance through the non-abbott guide catheter toward the very distal lesion; however, it could not cross.A non-abbott microcatheter was then used for support; however, the microcatheter aligned parallel with the bhw wire.Under angiography it was noted that the bhw guide wire had become broken in the proximal part.A trek balloon catheter was used to retrieve the broken bhw from the anatomy.A different bhw was used in the procedure without issue.There was no reported adverse patient sequela.No additional information was provided.

• Brand Name: ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8005643
• Report Number: 2024168-2018-08178
• Device Sequence Number: 19179036
• Product Code: DQX
• UDI-Device Identifier: 08717648015489
• UDI-Public: 08717648015489
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K013833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/25/2018

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: 07/31/2020
• Device Catalogue Number: 1000462H
• Device Lot Number: 8080871
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 10/25/2018
• 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: GUIDE CATH: CORDIS AL1MICROCATHETER: SUPERCROSS
• Outcome Attributed to Adverse Event: Required Intervention