MAUDE Adverse Event Report: CORDIS CORPORATION GC 7F 078 JR 4; CATHETER, PERCUTANEOUS

Model Number	77808200
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a 7f.078 judkins right 4 vista brite tip catheter was crumpled and cracked.The crack was noted during the preparation of the materials before the use on the patient.The procedure was completed with another unknown catheter.There was no reported patient injury.The product was stored and handled according to the instructions for use (ifu).There was no damage to the product packaging nor to the product when removed from the package.The intended procedure was a coronary angioplasty.The catheter was not used inside the patient.Additional procedural details were requested but are unknown.The device will be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17993633 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.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3, h6, and h10 complaint conclusion: as reported, a 7f.078 judkins right 4 vista brite tip catheter was crumpled and cracked.The crack was noted during the preparation of the materials before the use on the patient.The procedure was completed with another unknown catheter.There was no reported patient injury.The product was stored and handled according to the instructions for use (ifu).There was no damage to the product packaging nor to the product when removed from the package.The intended procedure was a coronary angioplasty.The catheter was not used inside the patient.The product was not returned for analysis.A product history record (phr) review of lot 17993633 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device or images for analysis, the reported customer event ¿catheter (body/shaft)- accordioned¿ and ¿catheter (body/shaft)- cracked - during prep¿ could not be confirmed.Shipping, storage and/or handling factors may have contributed to the reported events.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿store in a cool, dark, dry place.Do not use open or damaged packages.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¿ based on the information available and the phr 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.
Additional Manufacturer Narrative
This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
Complaint conclusion: as reported, a 7f.078 judkins right 4 vista brite tip catheter was crumpled and cracked.The crack was noted during the preparation of the materials before the use on the patient.The procedure was completed with another unknown catheter.There was no reported patient injury.The product was stored and handled according to the instructions for use (ifu).There was no damage to the product packaging nor to the product when removed from the package.The intended procedure was a coronary angioplasty.The catheter was not used inside the patient.Additional procedural details were requested but are unknown.A non-sterile unit of catheter ¿gc 7f 078 jr 4¿ was received.Per visual analysis, the catheter was thoroughly inspected and did not present any accordioned or cracked conditions on the body/shaft.However, several kinks were noticed located approximately at 7, 46, 54 and 75.5 cm from the distal tip.No other damages or anomalies were noticed at the inspected part.Per dimensional analysis, the inner diameter and outer diameter were measured, near the observed damages, and found to be within specification.A product history record (phr) review of lot 17993633 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) ~ accordioned¿ and ¿catheter (body/shaft) ~ cracked - during prep¿ was not confirmed during analysis of the returned device as there was no evidence of an accordioned or crack condition observed on the device.The unit, however, did present with several areas of kinking of the catheter.The exact cause for the kink conditions found on the catheter could not be determined as images of the catheter prior to shipping were not provided.Procedural/handling and or shipping factors may have contributed to the condition of the catheter.Information for safety is provided in the products labeling with the intent to make the user aware of the risks and warns the user to not use a guiding catheter that has been damaged in any way.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿inspect the catheter upon removal from packaging to verify that is undamaged, if damage is detected do not use the catheter and select another one.Based on the information available, the device analysis and the phr 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: GC 7F 078 JR 4
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14961066
• Report Number: 9616099-2022-05794
• Device Sequence Number: 17507627
• Product Code: DQY
• UDI-Device Identifier: 20705032022016
• UDI-Public: 20705032022016
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K972978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/12/2022

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: 12/31/2023
• Device Model Number: 77808200
• Device Catalogue Number: 77808200
• Device Lot Number: 17993633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2022
• Supplement Date Received by Manufacturer: 07/18/2022; 09/01/2022; 10/10/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 07/20/2022; 09/28/2022; 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANOTHER UNKNOWN CATHETER
• Patient Sex: Unknown