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

Model Number	1011834HJ
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The xience xpedition referenced is filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified right coronary artery.An unspecified xience alpine failed to cross for an unknown reason.Then a xience xpedition failed to cross due to anatomy and the whisper guide wire.As the xpedition was being removed it got stuck on the whisper guide wire.Both devices were removed as a single unit.Once outside the anatomy, it was noted that the guide wire had a fracture.There was no report of adverse patient effects or clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
The product was not returned to abbott vascular for analysis.Return of the sds and guide wire may have further aided the 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 and/or complaints reported from this lot.There was no damage noted to the guide wire during the inspection prior to use.The investigation determined the reported difficulty to advance/position, difficulty to remove resulting in core separation appear to be related to operational circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.Device code 1069 was removed.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified right coronary artery.An unspecified xience alpine failed to cross for an unknown reason.Then a xience xpedition failed to cross due to anatomy and the whisper guide wire.As the xpedition was being removed it got stuck on the whisper guide wire.Both devices were removed as a single unit.Once outside the anatomy, it was noted that the guide wire had a fracture.There was no report of adverse patient effects or clinically significant delay.No additional information was provided.Additional information received by the account subsequent to filing the initial report confirms that the whisper guide wire was broken in two pieces.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned guide wire and the reported separation was confirmed.The reported difficulty to advance and remove were unable to be confirmed due to the returned condition of the guide wire and sds.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the review of similar incident(s) there is no indication of a lot specific product quality issue.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 difficulty to advance/position, and difficulty to remove resulting in polymer separation appear to be related to operational circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.D10, h3: device status changed from not returned to returned.H6: method code 10 added.

• 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: 9770384
• Report Number: 2024168-2020-01870
• Device Sequence Number: 11316894
• Product Code: DQX
• UDI-Device Identifier: 08717648116094
• UDI-Public: 08717648116094
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K101116
• 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,Followup
• Report Date (Section B): 07/15/2020

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: 05/31/2020
• Device Model Number: 1011834HJ
• Device Catalogue Number: 1011834HJ
• Device Lot Number: 8061171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 04/13/2020; 06/24/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 04/20/2020; 07/15/2020
• 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: XIENCE XPEDITION; XIENCE XPEDITION
• Patient Age: 58 YR