MAUDE Adverse Event Report: CORDIS CORPORATION 6F .070 XB 3.5 100CM; CATHETER, PERCUTANEOUS

Model Number 67005400

Device Problem Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2019

Event Type  malfunction  

Manufacturer Narrative

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.This device is 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, three vista brite tip guiding catheters (6f.070 xb 3.5 100cm) were found to have holes in them.There was no patient injury reported.The devices were not clinically used and will be returned for analysis.There was no damage noted to the packaging for the devices.The devices were stored and handled per the instructions for use (ifu).The procedure was completed successfully.

Manufacturer Narrative

Complaint conclusion: prior to use, three vista brite tip guiding catheters (6f.070 xb 3.5 100cm) were found to have holes in them.There was no patient injury reported.The devices were not clinically used.There was no damage noted to the packaging for the devices.The devices were stored and handled per the instructions for use (ifu).The procedure was completed successfully.No other information was reported.The devices were returned for analysis.Three non- sterile units of product ¿6f.070 xb 3.5 100cm¿ were received coiled inside of a plastic bag, along with the three product labels.The catheters were unpacked in order to carry out the product evaluation.The devices were identified with number one, two and three to perform separate analysis for each catheter.2019-00064569-2 per visual analysis, two kinks were noted at 66 and 91.5 cm from the hub edge.No puncture/cut or other anomalies were noted.Per dimensional analysis, the inner diameter (id) and outer diameter (od) were measured near the damage and results were found within specification.A product history record (phr) review of lot 17834969 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 ¿catheter (body/shaft) - puncture/cut¿ events were not confirmed; no punctures or cuts were noted on the received devices.However, kinked/bent and compressed/crushed conditions were noted.The exact cause of these damages could not be conclusively determined during the analysis.Dimensional analysis results were found within specification and do not suggest that these damages could be related to the manufacturing process.Procedural/handling factors might have contributed to these events.As per the instructions for use (ifu), which is not intended as a mitigation, ¿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 reviews nor the product analyses suggest that the found damage could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: 6F .070 XB 3.5 100CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8512144
• MDR Text Key: 145116763
• Report Number: 9616099-2019-02854
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 20705032020166
• UDI-Public: 20705032020166
• Combination Product (y/n): N
• PMA/PMN Number: K021593
• 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: 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 67005400
• Device Catalogue Number: 67005400
• Device Lot Number: 17834969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Date Manufacturer Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 107