MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number C408646

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 11/13/2018

Event Type  Injury  

Event Description

Manufacturing related ref: 3008452825-2018-00404, 3008452825-2018-0402.During a procedure resistance with buckling was experienced when advancing three different dragonfly optis catheters with a non-abbott guidewire.A fourth dragonfly optis catheter was used to complete the procedure.No other issues were experienced and the patient left the procedure room in stable condition.Three days post operative, the patient presented to the emergency room with chest pressure.An angiogram revealed mid occlusion of the ramus; distal closure with dissection.Two stents were placed and the issue was resolved.The patient was in stable condition.(clinical study: (b)(6), patient id: (b)(6)).

Manufacturer Narrative

An event of dissection was reported.The reported event of a positioning issue was confirmed.The results of the investigation concluded that the sheath had been kinked in the proximal region.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the positioning issue is consistent with the kink.The cause of the kink is consistent with damage during use.The dragonfly optis imaging catheter instruction for use states that is resistance is encountered during advancement or withdrawal of the dragonfly optis imaging catheter, stop manipulation and evaluate under fluoroscopy.If the cause of resistance cannot be determined or mitigated, carefully remove the catheter from the patient.

• Brand Name: DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8130700
• MDR Text Key: 129253441
• Report Number: 3008452825-2018-00403
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00183739000654
• UDI-Public: 00183739000654
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: C408646
• Device Lot Number: 6543848
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/27/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER; DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 80 YR