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

Model Number	598943P
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of two reports submitted for the same event.A total of 13 devices are being reported for the same lot number associated with this event/report.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.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 or Problem 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.
Additional Manufacturer Narrative
This is one of two reports submitted for the same event.Please reference mfr report #: 9616099-2021-04253.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.13 sterile units of ¿gc 9f.098 str 55cm¿ were received in 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 on the mounting cards is not confirmed due to our procedures allow up to three no larger than 0.050¿ inclusions/stains per card no more than three, none longer than 3mm.The number of stains does not exceed three (3), and the stains identified do not measure above 0.050¿.A dimensional analysis was performed to verify if there were any inclusions larger than 0.050".Results were compared to material specification for sbs mounting cards.Per dimensional analysis results were found within specification.A product history record (phr) review of lot 17850141 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
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11304658
• Report Number: 9616099-2021-04252
• Device Sequence Number: 5036354
• Product Code: DQY
• UDI-Device Identifier: 20705032019092
• UDI-Public: 20705032019092
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K925131
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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: 02/28/2022
• Device Model Number: 598943P
• Device Catalogue Number: 598943P
• Device Lot Number: 17850141
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1