MAUDE Adverse Event Report: CORDIS CORPORATION GC 9F .098 STR 55CM; CATHETER, PERCUTANEOUS

Model Number 598943P

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

This is one of two reports submitted for the same event.Please reference mfr report #: 9616099-2021-04252.A total of 15 devices are being reported for the same lot number associated with this event/report.The devices are available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, twenty-eight (28) boxes of a.098¿ 9f 55cm vista brite tip straight (str) guiding catheter had particulate matter of suspected cardboard fragments found inside its sterile pouch.There was no damage noted to the packaging of the device.The product was received and inspected by quality control at customer¿s on-site facility.The actual product was not damaged.This product was not used.It was taken out of its box and inspected.It was not involved in any procedure.The devices will be returned for evaluation.

Manufacturer Narrative

This is one of two reports submitted for the same event.Please reference mfr report #: 9616099-2021-04252.Complaint conclusion: twenty-eight (28) boxes of a.098¿ 9f 55cm vista brite tip straight (str) guiding catheter had particulate matter of suspected cardboard fragments found inside its sterile pouch.There was no damage noted to the packaging of the device.The product was received and inspected by quality control at customer¿s on-site facility.The actual product was not damaged.This product was not used.It was taken out of its box and inspected.It was not involved in any procedure.The products were returned for analysis.15 non-sterile units of ¿gc 9f.098 str 55cm¿ were received at their original outer box packaging and sterility was not compromised.During the visual inspection no damages were noticed.However tiny stains were observed on the mounting cards inside the sealed pouches of the units.According with the pet analysis result, it was concluded that the contamination detected in the mounting card is not confirmed due to our procedures allow up to three no larger than 0.050¿ inclusions/stains per card.The number of stains does not exceed three (3), and the stains identified do not measure above 0.050¿.A review of the manufacturing documentation associated with lot 17852640 was performed and it was found that 28 defective units were rejected during the assembly of this lot.No issues were noted that may be related to the reported complaint.Dimensional analysis results were found within specification.A product history record (phr) review of lot 17852640 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿packaging/pouch/box ~ foreign material - in sterile package¿ was confirmed due to the stain observed on the received unit.However, per investigation results it was concluded that the unit was acceptable after measuring according to material specification for sbs mounting cards.The exact cause of the reported event could not be conclusively determined.Procedural factors, such as operator handling, may have contributed to the reported event.According to the instructions for use (ifu) which is not intended as a mitigation of risk, ¿precaution: do not use open or damaged packages.Inspect the guiding catheter before use to verify that its size, shape and condition are suitable for the specific procedure¿.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.

• Brand Name: GC 9F .098 STR 55CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11304603
• MDR Text Key: 234377946
• Report Number: 9616099-2021-04253
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 20705032019092
• UDI-Public: 20705032019092
• Combination Product (y/n): N
• PMA/PMN Number: K925131
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 598943P
• Device Catalogue Number: 598943P
• Device Lot Number: 17852640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1