MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE FLOPPY II GUIDE WIRE

Catalog Number	22359MS
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2018
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.Estimated date.(b)(4).The device was not returned for analysis.It should be noted that the hi-torque guide wires instructions for use, states: all hi-torque guide wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (ptca) and percutaneous transluminal angioplasty (pta).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 incidents from this lot.The investigation determined the reported difficulties appear to be related to deviation of the instructions for use (ifu) as the hi-torque floppy ii guide wire was used with a non-abbott atherectomy catheter for an atherectomy procedure (against the ifu); thus interaction with the non-abbott atherectomy catheter resulted in the reported difficulty to remove.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 procedure was performed to treat a lesion in the leg.A hi-torque floppy ii guide wire was advanced for an atherectomy procedure.On removal of the non-abbott atherectomy catheter resistance was met with the guide wire.The guide wire and atherectomy catheter were removed together as a single unit.An additional non-abbott guide wire and an unspecified balloon catheter were used to complete the procedure.There was no adverse patient effects and no reported clinically significant delay in the procedure.

• Brand Name: HI-TORQUE FLOPPY II 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: 8134502
• Report Number: 2024168-2018-09330
• Device Sequence Number: 10805048
• Product Code: DQX
• UDI-Device Identifier: 08717648080319
• UDI-Public: 08717648080319
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K060449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2018

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: 04/30/2020
• Device Catalogue Number: 22359MS
• Device Lot Number: 8050161
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 12/05/2018
• 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: PHOENIX ATHERECTOMY CATHETER