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

Catalog Number	1005357HJ
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/05/2019
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 period.The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional abbott devices referenced are being filed under separate medwatch reports.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the heavily calcified, moderately tortuous circumflex coronary artery.Before the procedure, a mini trek bdc was opened during prep and it was noted that the balloon was separated from the shaft.The device was not used and there was no patient involvement.A 3.5x23 mm xience sierra was implanted without issue; however, wire position was lost as the vessel closed for an unknown reason.A new balance middleweight (bmw) guide wire was advanced as well as a whisper guide wire and the whisper was thought to be in the true lumen of the vessel.The bmw went under and around a couple struts of the previously implanted xience sierra stent and over the whisper guide wire.The bmw was then jailed with a 2.25x18 mm xience sierra stent.The bmw was stuck and was not able to be removed.Balloon angioplasty was attempted in order to free the guide wire but it was unsuccessful.The bmw then separated and coiled into a ball.The tip of the whisper guide wire also separated due to the bmw guide wire wrapping around it.The separated portions of the guide wires both remain in the patient anatomy.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.Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.A review of the electronic lot history record (elhr), corrective action tracking system for the web (catsweb) database review and similar incident query for this product was not performed since the lot number was not reported.The investigation determined the reported core separation and difficulty to remove appear to be related to operational circumstances of the procedure.It is likely that during advancement through the previously implanted stent, the bmw guide wire got tangled and/or wrapped around the whisper wire resulting in the reported difficulty to remove and separations during retraction.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 9126537
• Report Number: 2024168-2019-12139
• Device Sequence Number: 16725340
• Product Code: DQX
• UDI-Device Identifier: 08717648037818
• UDI-Public: 08717648037818
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 12/10/2019

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 Catalogue Number: 1005357HJ
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 12/10/2019
• 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: 2.25X18 MM XIENCE SIERRA; 3.5X23 MM XIENCE SIERRA; BMW GUIDE WIRE
• Outcome Attributed to Adverse Event: Other