MAUDE Adverse Event Report: CORDIS CORPORATION IM/5.2F/100CM/ST+; DIAGNOSTIC CARDIOLOGY CATHETER (DQO)

Model Number N/A

Device Problem Defective Component (2292)

Patient Problem Vascular Dissection (3160)

Event Date 04/26/2016

Event Type  Injury  

Manufacturer Narrative

The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.(b)(6).

Event Description

During the use of a super torque plus diagnostic catheter (5f.2st+ i m 100cm), it was reported that the physician felt that the catheter made a slight dissection (subclavicular area) within the patient.The physician was concerned and switched catheter to the same shape as above to that of a 4f completing the case successfully.The physician felt the shape of the 5f was not correct as it normally is shaped.Upon patient returning to recovery he/she noted pain in their left arm, upon a ct scan the report found no findings of damage.There was no patient injury reported.The account packaged both the 5f (533-580) device reported to be faulty and the 4f catheter used to complete case for return.No additional info is available.

Manufacturer Narrative

Complaint conclusion: during the use of a super torque plus diagnostic catheter (5f.2st+ i m 100cm), it was reported that the physician felt that the catheter made a slight dissection (subclavicular area) within the patient.The physician was concerned and switched the catheter to the same shape as above to that of a 4f completing the case successfully.The physician felt the shape of the 5f was not correct as it normally is shaped.When the patient returned to recovery, he/she noted pain in their left arm.A ct scan was performed and found no damages.No additional information is available.A non-sterile unit of cath f5.2st+ i m 100cm diagnostic cardiology catheter was received for analysis coiled inside a plastic bag.Per visual analysis, no anomalies or shape relaxations were found.Also, according to shape master, the catheter shape was found within the tolerance zone.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.The complaint reported by the customer as ¿diagnostic cardiology catheter-catheter (body/shaft) - out of shape¿ was not confirmed as the diagnostic catheter shape was inspected and no shape relaxation or anomalies were found.According to the product instructions for use, procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with the possible complications.Complications may occur at any time during or after the procedure.Possible complications include, but are not limited to the following: air embolism, hematoma at the puncture site, infection, and perforation of the vessel wall.Neither the dhr review nor the product analysis suggests that the reported events could be related to the manufacturing process of the unit.Therefore, no corrective or preventative actions will be taken.

• Brand Name: IM/5.2F/100CM/ST+
• Type of Device: DIAGNOSTIC CARDIOLOGY CATHETER (DQO)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5675873
• MDR Text Key: 45784197
• Report Number: 9616099-2016-00262
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K862244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: N/A
• Device Catalogue Number: 533580
• Device Lot Number: 17367953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2016
• Initial Date FDA Received: 05/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/20/2016
• Date Device Manufactured: 11/30/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1