MAUDE Adverse Event Report: CORDIS CORPORATION CATH MB 5F PIG 65CM 8SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	532598C
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.A device history record (dhr) review of lot 17726398 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.
Event or Problem Description
As reported, two 5f super torque marker band pigtail (65cm 8sh) catheter packages were found to be non-sealed and without sterilization at the distal part of the package.There was no patient involvement.The product was stored and handle according to the instructions for use (ifu).The product was not exposed to long periods of sunlight.The humidity is not controlled in the storage room.At any time prior to use in the cath lab, the device was not exposed to long periods of sunlight, high temperatures or increased humidity.The device was not purposely opened in anticipation of use, then shelved again when not used.The device was stored on a shelf.
Additional Manufacturer Narrative
Complaint conclusion: as reported, two 5f super torque marker band pigtail (65cm 8sh) catheter packages were found to be non-sealed and without sterilization at the distal part of the packages.There was no patient involvement.The products were stored and handled according to the instructions for use (ifu).Prior to use in the cath lab, the devices were not exposed to long periods of sunlight, high temperatures or increased humidity.The devices were not purposely opened in anticipation of use, then shelved again when not used.The devices were stored on a shelf.Multiple attempts were made to obtain the return of the devices and requests for additional information have been unsuccessful.The device was not returned for analysis.A product history record (phr) review of lot 17726398 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The phr review does not suggest that the event reported by the customer could be related to the manufacturing process.The reported ¿packaging/pouch/box compromised sterility - seal open¿ could not be confirmed the as the devices were not returned for analysis and device photographs were not received.The exact cause could not be determined.Storage and handling factors may have contributed to the reported events.As per the precautions in the instructions for use (ifu), which is not intended as a mitigation, ¿store in cool, dark, dry place.Do not use if the package is open or damaged.Do not use the catheter if the ¿use by¿ date on the package label has expired.Do not resterilize.Exposure to temperatures above 54°c (130°f) may damage the catheter.¿ neither the phr reviews nor the event description suggests that the reported events could be related to the manufacturing process.Therefore, no corrective or preventative actions will be taken at this time.
Additional Manufacturer Narrative
This is one of two reports submitted for the same event.Please reference mfr report #: 9616099-2019-02770.Complaint conclusion: as reported, two 5f super torque marker band pigtail (65cm 8sh) catheter packages were found to be non-sealed and without sterilization at the distal part of the packages.There was no patient involvement.The products were stored and handled according to the instructions for use (ifu).Prior to use in the cath lab, the devices were not exposed to long periods of sunlight, high temperatures or increased humidity.The devices were not purposely opened in anticipation of use, then shelved again when not used.The devices were stored on a shelf.Two non-sterile super torque mb diagnostic catheters were received for analysis.The devices returned were still in the inner pouch.Per visual analysis, an opening at the distal portion of the pouch was noted, however the sides of the pouch were sealed.No evidence of manipulation was found.No evidence of remainings of the seal was noted on both device pouches which share the same characteristics.No other anomalies were observed.Sem analysis results showed that adhesive residues were observed on the edges of the film.However, no residues were observed on the middle section of the film where the seal should have been located.Also, no adhesive residues where observed on the pouch.No other anomalies were observed during sem analysis.The anomalies are considered to be related to the manufacturing process.The complaints reported by the customer as ¿packaging/pouch/box - compromised sterility - seal open¿ was confirmed.Visual analysis results revealed that the pouch was not sealed, and no evidence of manipulation was found.Also, an sem analysis was performed and no evidence of the seal was found.As per the precautions in the instructions for use (ifu), which is not intended as a mitigation, ¿store in cool, dark, dry place.Do not use if the package is open or damaged.Do not use the catheter if the ¿use by¿ date on the package label has expired.Do not resterilize.Exposure to temperatures above 54°c (130°f) may damage the catheter.¿ the reported condition is considered to be related to the manufacturing process as confirmed through the product evaluation.Therefore, the event has been escalated and a risk assessment has been initiated.

• Brand Name: CATH MB 5F PIG 65CM 8SH
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8405602
• Report Number: 9616099-2019-02771
• Device Sequence Number: 16726105
• Product Code: DQO
• UDI-Device Identifier: 20705032012048
• UDI-Public: 20705032012048
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K915836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/01/2020

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: 09/30/2020
• Device Model Number: 532598C
• Device Catalogue Number: 532598C
• Device Lot Number: 17726398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 02/08/2019; 04/09/2020; 05/08/2020
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 04/12/2019; 05/04/2020; 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1