MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 XB 3.5 100CM; CATHETER, PERCUTANEOUS

Catalog Number	67005400
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot (17763019) 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 or Problem Description
As reported, at the time of surgery when opening the packaging of the 6f vista brite tip guide catheter (.070 xb 3.5 100cm) was found to be cracked and it was informed that the product was damaged.There was no reported patient injury.The device was not used in the patient.The device will be returned for analysis.
Additional Manufacturer Narrative
At the time of surgery when opening the packaging of the 6f vista brite tip guide catheter (.070 xb 3.5 100cm) it was found to be cracked and it was informed that the product was damaged.There was no reported patient injury.The device was not used in the patient.Additional procedural details were requested but are unknown.The device was returned for analysis.One non-sterile unit of a 6f.070 xb 3.5 100cm guiding catheter was received for analysis.No original packaging box nor pouch bag were returned.Per visual analysis, the unit was thoroughly inspected, and no crack was found on the unit.However, multiple kinks were observed at 20.0cm, 87.2cm, and at 96.0 cm from the inner diameter (id) band.Traces of dried blood residues were observed on the body shaft of the catheter.No other anomalies were observed.A product history record (phr) review of lot 17763019 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event by the customer as ¿catheter (body/shaft)- cracked - during prep¿ was not confirmed since no crack was found on the returned unit.However, multiple kinks were observed on the device as received.The root cause of the kinked conditions on the body shaft of the unit could not be conclusively determined during the analysis.Procedural or handling factors may have contributed to the reported event.According to the instructions for use (ifu), which is not intended as a mitigation of risk, ¿store in a cool, dark, dry place.Do not use open or damaged packages.Do not resterilize.Do not expose to organic solvents.Inspect the guiding catheter before use to verify that its size, shape, and condition are suitable for the specific procedure.¿ the recommended procedure section in the ifu states, ¿remove the guiding catheter from its packaging.Inspect the guiding catheter upon removal from packaging to verify that it is undamaged.Warning: do not use a guiding catheter that has been damaged in any way.If damage is detected, replace with an undamaged guiding catheter.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.
Additional Manufacturer Narrative
At the time of surgery when opening the packaging of the 6f vista brite tip guide catheter (.070 xb 3.5 100cm) it was found to be cracked and it was informed that the product was damaged.There was no reported patient injury.The device was not used in the patient.The device was not returned for analysis.A product history record (phr) review of lot 17763019 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter (body/shaft) cracked - during prep¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Procedural or handling factors may have contributed to the reported event.According to the safety information in the instructions for use ¿inspect the guiding catheter before use to verify that its size, shape and condition are suitable for the specific procedure.¿ neither the phr nor the very limited information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.Corrected data: device available for evaluation.

• Brand Name: 6F .070 XB 3.5 100CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8647031
• Report Number: 9616099-2019-02980
• Device Sequence Number: 2386947
• Product Code: DQY
• UDI-Device Identifier: 20705032020166
• UDI-Public: 20705032020166
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K021593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 67005400
• Device Lot Number: 17763019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 06/25/2019; 10/16/2019
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 06/28/2019; 11/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1