MAUDE Adverse Event Report: AV-TEMECULA-CT ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE; GUIDE WIRES

Catalog Number	1001782S
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	Vessel Or Plaque, Device Embedded In (1204)
Date of Event	12/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Evaluation summary: the device was returned for analysis.The reported detachment was able to be confirmed.The reported difficult to position and difficult to remove were unable to be replicated in a testing environment due to the condition of the returned device.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.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.Manipulation of the device resulted in the noted stretched coils and ultimately resulted in 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 the balance middle weight (bmw) guide wire as advanced to the heavily calcified distal right coronary artery (rca).There was resistance advancing rapid exchange balloon dilatation catheters (bdc) over this wire, so the plan was to switch this bmw out for a more supportive wire.An otw bdc was loaded over this bmw as a placeholder for the other wire.During attempts to remove the bmw, resistance was met and the distal tip of the bmw separated in the rca.Device interaction with the bdc along with the heavy calcium was suspected to have caused the tip separation of the bmw guide wire.Attempts to remove the bmw tip with a snare were made, but were unsuccessful.The tip was lodged in the calcium over an area that was intended to be treated with a stent.A 3.0x12 mm xience sierra stent was implanted in the rca covering the separated tip of the bmw.There was no adverse patient sequela.No additional information was provided.

• Brand Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE
• Common Device Name: GUIDE WIRES
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8228321
• Report Number: 2024168-2019-00200
• Device Sequence Number: 1746302
• Product Code: DQX
• UDI-Device Identifier: 08717648013843
• UDI-Public: 08717648013843
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2019

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: 06/30/2019
• Device Catalogue Number: 1001782S
• Device Lot Number: 7071171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2018
• Initial Report FDA Received Date: 01/08/2019
• 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