MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

Catalog Number	1011880J
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 identified no other similar incidents reported from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.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 heavily calcified lesion in the mid left anterior descending artery.A ht bmw elite guide wire and non-abbott micro-catheter were advanced to the lesion; however, resistance between the devices was felt when attempting to remove the guide wire.The micro-catheter and guide wire were removed together as a single unit.The guide wire remained in the micro-catheter as it was impossible to remove it.The procedure was successfully completed with a non-abbott device.There was no clinically significant delay in the procedure and no adverse patient effects.No additional information was provided.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 6504593
• Report Number: 2024168-2017-03375
• Device Sequence Number: 1279176
• Product Code: DQX
• UDI-Device Identifier: 08717648144790
• UDI-Public: (01)08717648144790(17)190131(10)7022461
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K103101
• 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
• Report Date (Section B): 04/19/2017

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: 01/31/2019
• Device Catalogue Number: 1011880J
• Device Lot Number: 7022461
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2017
• Initial Report FDA Received Date: 04/19/2017
• 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: MICRO-CATHETER: SURECROSS