MAUDE Adverse Event Report: CORDIS CORPORATION SMART 120 150, SFA - 7X150MM; CATHETER, BILIARY, DIAGNOSTIC

Model Number	C07150ML
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot (17881694) 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.
Event or Problem Description
As reported, the 120 150 7x150mm smart vascular self-expanding stent delivery system (ses) was damaged upon opening the packaging.The damaged means separated, and it was noted at the shaft of the stent/pusher.As stated by the customer, they were not matched up, therefore, they could not feed a wire thru the lumen.There was no damaged noted to the packaging of the device.There was no reported patient injury.The procedure was a peripheral procedure.The device was prepped as per the instruction for use (ifu).The procedure was completed using a new unknown stent.The device will be returned for evaluation.
Additional Manufacturer Narrative
A smart 7mm x 150mm vascular self-expanding stent delivery system (ses) was damaged upon opening the packaging.The damage means separated, and it was noted at the shaft of the stent/pusher.As stated by the customer, they were not matched up, therefore, they could not feed a wire thru the lumen.There was no damage noted to the packaging of the device.The procedure was a peripheral procedure.The device was prepped as per the instruction for use (ifu).The procedure was completed using a new unknown stent.There was no reported patient injury.The product was returned for analysis.One non-sterile smart 7mm x 150 mm was received for analysis inside a plastic bag.No original packaging was returned.Per visual analysis, the stent of the unit was received in-place not deployed.The strain relief was observed bent.The valve was received partially locked.Neither the body of the catheter nor the hypo tube rod were observed separated.No other anomalies were observed.The reported ¿stent delivery system (sds)-ses - separated - during prep¿ was not confirmed since neither the body of the catheter nor the hypo tube rod were observed separated.However, the exact cause of the bend observed on the strain relief could not be conclusively determined during the analysis.Handling factors may have led to the reported event.According to the instructions for use, which are not intended as a mitigation of risk, ¿after careful inspection of the pouch looking for damage to the sterile barrier, carefully peel open the pouch and extract the stent delivery system from the tray.Examine the device for any damage.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.Evaluate the distal end of the catheter to ensure that the stent is contained within the outer sheath.Do not use if the stent is partially deployed.Advance the device over the guidewire through the hemostatic valve and sheath introducer.Note: if resistance is met during delivery system introduction, the system should be withdrawn, and another system should be used.¿ neither the phr review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: SMART 120 150, SFA - 7X150MM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 9574462
• Report Number: 9616099-2020-03466
• Device Sequence Number: 2287397
• Product Code: FGE
• UDI-Device Identifier: 20705032063439
• UDI-Public: 20705032063439
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K042969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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: 06/30/2021
• Device Model Number: C07150ML
• Device Catalogue Number: C07150ML
• Device Lot Number: 17881694
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1