MAUDE Adverse Event Report: CORDIS DE MEXICO 6F .070 JR 4 100CM; CATHETER, PERCUTANEOUS

Model Number	67008200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
During the use of a 6f vista brite guiding catheter, it was reported that the patient lift her arm and all the material came out.Neurological symptoms appeared and a ct scan was performed.The patient was transferred to the neurology department at the (b)(6) where they took out debris from the neurovascular system.A patient present at the emergency and required an angiography.The case was performed normally via radial access.
Additional Manufacturer Narrative
During the use of a 6f vista brite guiding catheter, it was reported that the patient lifted her arm and all the material came out.Neurological symptoms appeared and a ct scan was performed.The patient was transferred to the neurology department at the (b)(6) where they removed debris from the neurovascular system.The case was performed normally via radial access.The device was not returned for analysis.A device history record review of lot 17535972 was performed and showed that the lot met all requirements per the applicable manufacturing quality plan and that there were no anomalies during the manufacturing.Based on the limited information provided, 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.The cordis guiding catheter has a large nontapered lumen that allows contrast medium injections and pressure monitoring and facilitates the intravascular passage of interventional devices.The instruction for use states to inspect the guiding catheter before use to verify that its size, shape and condition are suitable for the specific procedure.Furthermore, extreme care must be taken to avoid damage to the vasculature through which the guiding catheter passes.The guiding catheter may occlude smaller vessels.Care must be taken to avoid complete blood flow blockage.Based on the available information there is no evidence to suggest that the event was design or manufacturing related.The dhr review does not suggests that the reported failures could be related to the manufacturing process of the unit.Therefore no corrective action will be taken.

• Brand Name: 6F .070 JR 4 100CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 6267542
• Report Number: 9616099-2017-00873
• Device Sequence Number: 1477197
• Product Code: DQY
• UDI-Device Identifier: 20705032020432
• UDI-Public: 20705032020432
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2017

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 Expiration Date: 06/30/2019
• Device Model Number: 67008200
• Device Catalogue Number: 67008200
• Device Lot Number: 17535972
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2017
• Supplement Report FDA Received Date: 02/21/2017
• 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: Required Intervention