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

Model Number SRD5602

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Myocardial Infarction (1969); Vascular Dissection (3160)

Event Date 11/30/2016

Event Type  Death  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

It was reported during a diagnostic heart catheterization, a dissection in the left main occurred.A 'hockeystick catheter¿ (tempo diagnostic catheter) was used during the procedure.The patient was transported to the university medical center in (b)(6) for an emergency coronary artery bypass grafting (cabg).The patient expired several days after the surgery.The incident was reported to the (b)(6) as a possible calamity.An intern investigation was also initiated. the catheter was discarded after the procedure.A non-cordis catheter and a non-cordis device were also used in the procedure.A vasospasm occurred in the right coronary artery at the location of the sheath.Aside from the dissection, the patient experienced a non-st elevation myocardial infarction (nstemi).When the patient was in the university medical center, the circumflex (cx) artery was closed with minor collateral, however, the patient experiences another dissection right after a vasospasm.The patient was on heparin, verapamil, ntg, fentanyl during the procedures.The patient was said to have been hemodynamically stable.Additional procedural details were requested but are unknown.

Manufacturer Narrative

After further review of additional information received the following have been updated accordingly: date received by mfr, type of reports, if follow-up, what type? and evaluation codes.  during a diagnostic heart catheterization a dissection in the left main occurred.A 'hockeystick catheter¿ (tempo diagnostic catheter) was used during the procedure.The patient was transported to the university medical center in groningen for an emergency coronary artery bypass grafting (cabg).The patient expired several days after the surgery.The incident was reported to the igz (inspection for health care) as a possible calamity.An intern investigation was also initiated. the catheter was discarded after the procedure.A non-cordis catheter and a non-cordis device were also used in the procedure.A vasospasm occurred in the right coronary artery at the location of the sheath.Aside from the dissection the patient experienced a non-st elevation myocardial infarction (nstemi).When the patient was in the university medical center the circumflex (cx) artery was closed with minor collateral, however, the patient experiences another dissection right after a vasospasm.The patient was on heparin, verapamil, ntg, fentanyl during the procedures.The patient was said to have been hemodynamically stable.Additional procedural details were requested but are unknown.The device was not returned for evaluation as it was discarded after the procedure by the site.Review of lot 17517213 revealed no anomalies during the manufacturing and inspection processes that can be related to the reported complaint.Death, coronary dissection and myocardial infarction are well-known and extensively documented potential complications of this type of procedure and are listed in the instructions for use (ifu) as such.A dissection is a tear within the wall of the blood vessel which allows blood to separate the wall layers.The blood can then become trapped and bulge causing a narrowing or blockage of the vessel that can cause a heart attack since blood flow is unable to reach the heart muscle.Although a definitive root cause cannot be determined, patient history, clinical status, comorbidities, and pharmacological factors are possible contributing factors for the patient outcome.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 DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: cecil navajas ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6203714
• MDR Text Key: 63257147
• Report Number: 9616099-2016-00815
• 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: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2016
• 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: 11/30/2016
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2016
• 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: ULTIMATE CATHETER, TERUMO CATHETER
• Patient Outcome(s): Death
• Patient Age: 41 YR
• Patient Weight: 44