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

Catalog Number	1010482-HJ
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual and dimensional inspections were performed on the returned device.The reported separation was confirmed although the reported difficulty to remove and physical resistance were unable to be confirmed due to the condition of the returned device.The investigation determined the reported difficulties to be related to the patient anatomical conditions.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.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 chronic total occlusion (cto) mid right coronary artery (rca) and a heavily calcified narrow lesion in the proximal rca.A hi-torque pilot 200 guide wire (gw) was advanced past the proximal rca without resistance, but while crossing the mid rca resistance was felt with no force applied.After crossing the cto, an unspecified balloon was advanced and angioplasty was performed.With the balloon in place, during attempted guide wire exchange, the pilot gw was pulled back, resistance was felt against the cto, and, though no force was applied, the tip separated in the vessel.The tip was successfully snared.The procedure was aborted with plans to treat the target lesion at another time.There was no adverse patient sequela reported.No additional information was provided.

• Brand Name: HI-TORQUE PILOT 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: 6881182
• Report Number: 2024168-2017-07637
• Device Sequence Number: 16314359
• Product Code: DQX
• UDI-Device Identifier: 08717648073908
• UDI-Public: 08717648073908
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K060449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/20/2017

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: 01/31/2018
• Device Catalogue Number: 1010482-HJ
• Device Lot Number: 6022471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 09/20/2017
• 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
• Patient Age: 79 YR
• Patient Weight: 65