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

Model Number	67012600
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17758687 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, there was evidence of fracture at the time the physician passed the 6f.070 xb rca 100cm vista brite tip guiding catheter to the table.Therefore, they changed the device with another unknown catheter and the procedure is performed.The patient comes out in perfect condition.This is a case of cardiac catheterization.The device was stored and handled per the instructions for use (ifu).The device was prepped per the ifu.There was no damage noted to the packaging of the device.There was no difficulty removing the product from the packaging.The device will be returned for evaluation.
Additional Manufacturer Narrative
There was evidence of fracture at the time the physician passed the 6f.070 xb rca 100cm vista brite tip guiding catheter to the table.Therefore, they changed the device with another unknown catheter and the procedure was performed.The patient came out in perfect condition.This is a case of cardiac catheterization.The device was stored and handled per the instructions for use (ifu).The device was prepped per the ifu.There was not any damage noted to the packaging of the device.There was no difficulty removing the product from the packaging.The device was not returned for analysis.A product history record (phr) review of lot 17758687 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Based on the information provided, it is not possible to draw a clinical conclusion between the device and the reported event.Without the return of the device for analysis, the reported customer event ¿catheter (body/shaft)¿ cracked - during prep¿ could not be confirmed and the exact root cause could not be determined.Storage or handling factors may have contributed to the reported event.Per the 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 information available 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
There was evidence of fracture at the time the physician passed the 6f.070 xb rca 100cm vista brite tip guiding catheter to the table.Therefore, they changed the device with another unknown catheter and the procedure was performed.The patient came out in perfect condition.This is a case of cardiac catheterization.The device was stored and handled per the instructions for use (ifu).The device was prepped per the ifu.There was not any damage noted to the packaging of the device.There was no difficulty removing the product from the packaging.A non-sterile unit of a vista brite tip catheter (6f.070 xb rca 100cm) was received coiled inside of a clear plastic bag.During the inspection a kinked/bent condition on the body of the catheter was observed located at 6, 13, 17, 65, 88 and 98 cm from the distal tip.In addition, a compressed/kink/twisted condition with cracks was observed located at 54 cm from the distal tip.No other damages or anomalies were observed on the returned device.Dimensional analysis was performed to verify the correct catheter inner diameter (id) and outer diameter (od).Dimensional analysis results were found within specification.A product history record (phr) review of lot 17758687 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿catheter (body/shaft)- cracked - during prep¿ was confirmed since a crack was observed at 54 cm from the distal tip of the catheter.The compressed/kink/twist condition of the area may have caused this crack.Additional kinks were also noted on the catheter, however the dimensional analysis was found within specification.Storage conditions or handling factors may have contributed to the reported event.Per the 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 product analysis nor the phr review suggests that the found damages could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.
Additional Manufacturer Narrative
After further review of additional information received the following sections d10, g4, g7, h1, h2, h3, and h6 have been updated accordingly.A non-sterile unit of catheter (6f.070 xb rca 100cm) was received coiled inside of a clear plastic bag.The part was unpacked in order to proceed with the product evaluation.During the inspection a kinked/bent condition on the body of the catheter was observed located at 6, 13, 17, 65, 88 and 98 cm from the distal tip.In addition, a compressed/kink/twisted condition with cracks was observed located at 54 cm from the distal tip.No other damages or anomalies were observed on the returned device.Dimensional analysis was performed to verify the correct catheter inner diameter (id) and outer diameter (od), measurements were taken near to the damages.The dimensional analysis results were found within specification.Additional information is pending and will be submitted within 30 days upon receipt.

• Brand Name: 6F .070 XB RCA 100CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 9322922
• Report Number: 9616099-2019-03350
• Device Sequence Number: 19457332
• Product Code: DQY
• UDI-Device Identifier: 20705032020654
• UDI-Public: 20705032020654
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/18/2020

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: 01/31/2021
• Device Model Number: 67012600
• Device Catalogue Number: 67012600
• Device Lot Number: 17758687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 12/18/2019; 01/17/2020; 02/17/2020
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 12/19/2019; 02/14/2020; 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.