MAUDE Adverse Event Report: ABBOTT VASCULAR HT WHISPER GUIDE WIRES WITH HYDROPHILIC COATING

Catalog Number	1011834HJ
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 periodthe device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the whisper guide wire was inserted to go across the stent struts of a deployed stent for a crush technique in the diagonal/left anterior descending coronary artery bifurcation.There was no resistance felt during advancement to the stent.The guide wire reached the bifurcation, but before it reached the stent, it was noted on fluoro that the guide wire had separated in two pieces.A balloon dilatation catheter (bdc) was inserted past the separated wire segment and the bdc was inflated.The inflated bdc was able to pull the separated wire into the guide catheter.At that point, all the devices were removed from the patient as a unit.A new whisper 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
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 returned for analysis.The reported material separation was able to be 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 incidents from this lot.As there was no damage noted to the guide wire during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.Corrected patient age in years.

• Brand Name: HT WHISPER GUIDE WIRES WITH HYDROPHILIC COATING
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9126505
• Report Number: 2024168-2019-12138
• Device Sequence Number: 2425325
• Product Code: DQX
• UDI-Device Identifier: 08717648116094
• UDI-Public: 08717648116094
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K101116
• 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,Followup
• Report Date (Section B): 12/11/2019

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: 03/31/2021
• Device Catalogue Number: 1011834HJ
• Device Lot Number: 9042971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 12/11/2019
• 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
• Patient Age: 37 YR
• Patient Weight: 63