MAUDE Adverse Event Report: AV-TEMECULA-CT HT POWERTURN ULTRA FLEX; GUIDE WIRE

Catalog Number	1044590
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	06/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 for the reported lot was performed and revealed no other incidents.The investigation determined the reported difficulties, treatment and patient effect appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the procedure was to treat a 70% stenosed and heavily calcified de novo lesion in the proximal ramus posterolateralis dexter artery.A non-abbott guiding catheter and guide wire were advanced without issues.A ht powerturn ultra flex guide wire was advanced without issues; however, after advancement of an unknown balloon catheter it was noticed that the distal end of the wire separated.At this point it was not possible to recover the wire.An attempt to use a guideliner-catheter for recovery was made, but it was confirmed that the distal end of the ht powerturn ultra flex guide wire separated.A non-abbott guide wire was advanced and a 1.2x15mm and 2.0x20mm mini trek bdc were advanced for successful pre-dilatation.A 2.5x24mm non-abbott stent was implanted and successfully embedded the separated piece of the guide wire.The procedure was completed successfully and the patient is doing well.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Was initially reported that the device would not be returning for analysis; however, the device was returned.Visual and dimensional inspections were performed.The reported separation was confirmed although the reported difficult to remove was unable to be confirmed due to the noted separation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HT POWERTURN ULTRA FLEX
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6682873
• Report Number: 2024168-2017-05579
• Device Sequence Number: 19325690
• Product Code: DQX
• UDI-Device Identifier: 08717648173899
• UDI-Public: (01)08717648173899(17)181130(10)6120261
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K112957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2017

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: 11/30/2018
• Device Catalogue Number: 1044590
• Device Lot Number: 6120261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Initial Date Received by Manufacturer: 06/13/2017
• Supplement Date Received by Manufacturer: 08/09/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 08/11/2017
• 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