MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE WHISPER ES GUIDE WIRE; GUIDE WIRES

Catalog Number	1011835HJ
Health Effect - Clinical Code	Perforation (2001)
Date of Event	10/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical devices:: guide wires: scion, pilot 200, viper 350, stents: four synergy stents (2.5x38, 3.0x38, 3.5x38, 4.0x15 mm).The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of perforation is listed in the hi-torque guide wires instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined and 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 whisper es (extra support) guide wire was advanced into the chronic total occlusion in the distal right coronary artery (rca).After four non-abbott stents were implanted in the rca, a localized, guide wire perforation in the distal rca was noted.A 2.8x16 mm graftmaster stent was implanted to successfully treat the perforation.No additional information was provided.

• Brand Name: HI-TORQUE WHISPER ES 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: 7012136
• Report Number: 2024168-2017-08820
• Device Sequence Number: 13946846
• Product Code: DQX
• UDI-Device Identifier: 08717648116124
• UDI-Public: 08717648116124
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/08/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 1011835HJ
• Device Lot Number: 7073171
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 11/08/2017
• 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: 66 YR
• Patient Weight: 104