MAUDE Adverse Event Report: CORDIS CORPORATION SABER 6MM20CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48006020X
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	02/21/2020
Type of Reportable Event	Serious Injury
Additional 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.It is unknown if the device will be returned for testing and evaluation.   additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the balloon detached from a saber 6mm20cm 150 percutaneous transluminal angioplasty (pta) and embolized down to the tibioperoneal (tp) trunk.The balloon somehow attached to the unknown guidewire and was able to be successfully removed from the patient without issue.There was no patient injury reported.The device will be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the balloon detached from a saber 6mm x 20cm 150 percutaneous transluminal angioplasty (pta) and embolized down to the tibioperoneal (tp) trunk.The balloon somehow attached to the unknown guidewire and was able to be successfully removed from the patient without issue.There was no patient injury reported.The product was not returned for analysis.A product history record (phr) review of lot: 82171796 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿balloon separated - in-patient¿ could not be confirmed as the device was not returned for analysis.The exact causes could not be determined.It is likely procedural factors and handling of the device contributed to the reported events.However, without the return of the device for analysis and with the limited amount of information provided, it is difficult to draw a clinical conclusion between the device and the event reported.Device embolization resulted from the balloon detaching from the shaft of the catheter and migrated to the tibioperoneal trunk.Potential adverse events are associated with any procedure in which multiple devices are introduced into the patient.According to the safety information of the instructions for use ¿if resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.Proper functioning of the catheter depends on its integrity.Care should be used when handling the catheter.Damage may result from kinking, stretching, or forceful wiping of the catheter.Forceful handling can result in catheter separation and the subsequent need to use a snare or other medical interventional techniques to retrieve the pieces.Always verify integrity of the catheter after removal.Potential complications include but are not limited to: embolism.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective or preventive action will be taken at this time.

• Brand Name: SABER 6MM20CM 150
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 9897709
• Report Number: 9616099-2020-03606
• Device Sequence Number: 2788865
• Product Code: LIT
• UDI-Device Identifier: 20705032069639
• UDI-Public: 20705032069639
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K971010
• 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
• Report Date (Section B): 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 48006020X
• Device Catalogue Number: 48006020X
• Device Lot Number: 82171796
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 78