MAUDE Adverse Event Report: CORDIS CORPORATION 5F TEMPO 0.038 100CM BL; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number SRD5602

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

Patient Problem Vascular Dissection (3160)

Event Date 11/11/2016

Event Type  Injury  

Manufacturer Narrative

A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.  additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, "dissection of the right coronary artery (rca) and possibly the circumflex (cx) during a diagnostic heart catheterization", a  100 cm.5 fr.Tempo 0.038 bl was used. a ¿hockeystick catheter¿ was used.The patient was transported to the medical center for an emergency coronary artery bypass grafting (cabg). the incident was reported to the igz (inspection for health care) and an internal investigation is initiated.Additional information has been received.The procedure date was (b)(6) 2016.The catheter was thrown away after the procedure.The used catheters: left coronary artery (lca): ultimate 1 and the right coronary artery (rca): hockeystick.Results: blood pressure aorta: 103/55 mmhg.Lca: irregularities in vessel wall, left anterior descending artery (lad) prox: irregularities in vessel wall, lad mid: 70-90% d1: 70-90% d2: 70-90 % rc prox: closed.Rca: small dissection proximal after vasospasm, collateral to left.Conclusion: closed cx with minor collateral (right).Dissection right after vasospasm.Suggested policy: revascularization.Medication during procedure: 1 x ntg s.L.And fentanyl.Hemodynamic stable.The information on the patient: weight: (b)(6) kg.Length: (b)(6) cm.Bmi: (b)(6) blood pressure: 130/70.

Manufacturer Narrative

Complaint conclusion-  as reported, "dissection of the right coronary artery (rca) and possibly the circumflex (cx) during a diagnostic heart catheterization", a 100 cm.5 fr.Tempo 0.038 bl was used.A ¿hockeystick catheter¿ was used.The patient was transported to the medical center for an emergency coronary artery bypass grafting (cabg). the incident was reported to the igz (inspection for health care) and an internal investigation is initiated.Additional information has been received.The procedure date was (b)(6) 2016.The catheter was thrown away after the procedure.The used catheters: left coronary artery (lca): ultimate 1 and the right coronary artery (rca): hockeystick.Results: blood pressure aorta: 103/55 mmhg.Lca: irregularities in vessel wall, left anterior descending artery (lad) prox: irregularities in vessel wall, lad mid: 70-90% d1: 70-90%.The 70-90 % rc prox: closed.Rca: small dissection proximal after vasospasm, collateral to left.Conclusion: closed cx with minor collateral (right).Dissection right after vasospasm.Suggested policy: revascularization.Medication during procedure: 1 x ntg s.L.And fentanyl.Hemodynamic stable.The information on the patient: weight: (b)(6).Length: (b)(6).Bmi: (b)(6) blood pressure: 130/70.History: 2002: peripheral vascular disease 2011: tia brain.Cardiovasc risc: heart & vessel disease in family, smoking (6-7 cig a day), hypertension, hypercholesterolemia. on (b)(6) 2016: hemoglobin 9.4 mmol/l, hematocrit 0.44 l/l, erythrocyten 4.61 10^12/l, mcv 95 fl, mch 2036 amol, rdw 12.5 %, trombocyten 160 10^9/l, leukocyten 8.7 10^9/l, natrium 145 mmol/l, kalium 4.5 mmol/l, ureum 5.3 mmol/l, kreatinine 91 umol/l, estimated gfr (ckd-epi) 77 ml/mn/1.73.The product was not returned for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan. spontaneous coronary artery dissection (scad) is a rarely reported cause of myocardial infarction and sudden cardiac death.Average age of presentation is (b)(6) and 70% of cases are reported in women, of which, 30% were noted either during the third trimester of pregnancy or in the early postpartum period.Scad may be the result of an intimal rupture, with subsequent disruption of the vessel wall leading to a double lumen.The etiology of spontaneous coronary artery dissection remains unclear.Coronary atherosclerosis and the peripartum period are most commonly associated with the development of scad.Other predisposing factors include hypertension, connective tissue disorders (marfan¿s syndrome, ehlers-danlos syndrome), vasculitis (for example, polyarteritis nodosa, systemic lupus erythematosus and eosinophilic arteritis), antiphospholipid antibody syndrome, and inflammatory bowel disease.Early diagnosis of spontaneous coronary artery dissection can be determined through coronary angiography.Subsequent treatment may include urgent coronary artery bypass grafting.The relationship between the coronary artery dissection and the device is not clear.Without medical records and films for review, it is not possible to draw a conclusion about a clinical relationship between the device and the event.  without the return of the device for analysis, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.Based on the device history record review, there is no indication that the event is related to the device design or manufacturing process. therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: 5F TEMPO 0.038 100CM BL
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32580 ; MX 32580
• Manufacturer Contact: cecil navajas ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6203755
• MDR Text Key: 63257573
• Report Number: 9616099-2016-00818
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: SRD5602
• Device Catalogue Number: SRD5602
• Device Lot Number: 17517213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/12/2017
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2016
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HOCKEYSTICK CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention