MAUDE Adverse Event Report: AV-TEMECULA-CT HT VERSATURN GUIDE WIRE

Catalog Number	1013319
Health Effect - Clinical Codes	Perforation (2001); Cardiac Tamponade (2226)
Date of Event	11/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Dilatation catheter: trek 2.0 x 20 mm, braun sequent please drug eluting balloon stent: xience prox 2.25 x 12 mm.The device was not returned for analysis.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.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 initial procedure was to treat a lesion in the third obtuse marginal branch of the left circumflex (lcx) coronary artery.A 014 ht versaturn guide wire was used for the procedure and the procedure was completed with no issues noted.After returning to the cardiac ward following the procedure, the patient's condition started to deteriorate.It was discovered that the patient had experienced cardiac tamponade.Re-intervention was performed and it was noted that a perforation had occurred in the vessel most likely due to the use of the versaturn guide wire used in the initial procedure.Pericardiocentesis and coiling of the vessel were performed to stop the bleeding and stabilize the patient.No additional information was provided.

• Brand Name: HT VERSATURN 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: 6230566
• Report Number: 2024168-2017-00166
• Device Sequence Number: 1070197
• Product Code: DQX
• UDI-Device Identifier: 08717648198458
• UDI-Public: (01)08717648198458
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 01/06/2017

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 Catalogue Number: 1013319
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2016
• Initial Report FDA Received Date: 01/06/2017
• 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: Hospitalization; Required Intervention