MAUDE Adverse Event Report: CORDIS DE MEXICO SABER 8MM4CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48008004S
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2016
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.
Event or Problem Description
It was reported that the tip of the catheter of a saber balloon 8mm4cm 90 has come off while it was being put on the wire.There was no patient injuries.The device was never used in the patient.The device is available for analysis.
Additional Manufacturer Narrative
This device is available for analysis but has not yet been received.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
It was reported that the tip of the catheter of a saber balloon 8mm4cm 90 has come off while it was being put on the wire.Another 8mm x 4cm saber balloon was used to complete the procedure.There was no patient injuries.The device was never used in the patient.The device is available for analysis.Additional information was received and there were no anomalies noted when removed from the package.There were no anomalies noted during prep.There were no unusual force used when putting the device on the wire.A non cordis v18 200 cm guidewire was used; the same guidewire was used to complete the procedure.There were no kinks noted in any of the devices.The doctor said that with the v18 sometimes the blood clumps on the wire (even after cleaning the wire) the doctor seemed to think that the tip was a lot smaller and broke off when it came into contract with the clump of blood.The saber couldn¿t be advanced anymore (outside of the patient and sheath) and looking under closer examination, it was noticed that the tip had come off.The same thing that happened with the 2nd device which had the same lot number.There were 3 unopened balloon on the shelve with the same lot number which will be returned.
Additional Manufacturer Narrative
The tip of the catheter of a saber 8mmx4cm balloon catheter came off while it was being put on the wire.Another 8mm x 4cm saber balloon was used to complete the procedure.There was no patient injuries.The device was never used in the patient.Additional information was received and there were no anomalies noted when removed from the package.There were no anomalies noted during prep.There was no unusual force used when putting the device on the wire.A non-cordis 200cm guidewire was used; the same guidewire was used to complete the procedure.There were no kinks noted in any of the devices.The doctor said that with that particular guidewire sometimes the blood clumps on the wire (even after cleaning the wire) and the doctor seemed to think that the tip was a lot smaller and broke off when it came into contract with the clump of blood.The saber couldn't be advanced anymore (outside of the patient and sheath) and looking under closer examination, it was noticed that the tip had come off.The same thing then happened with the 2nd device which had the same lot number.There were 3 unopened balloon on the shelf with the same lot number which will be returned.The device was not returned for analysis.A device history record (dhr) review of lot 17326494 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿distal tip separated - during prep¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Handling or procedural factors may have contributed to the reported event.According to the instructions for use ¿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.¿ neither the dhr nor the limited information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.

• Brand Name: SABER 8MM4CM 90
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 6105963
• Report Number: 9616099-2016-00729
• Device Sequence Number: 890039
• Product Code: LIT
• UDI-Device Identifier: 20705032068908
• UDI-Public: 20705032068908
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K971010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/30/2016

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: 08/31/2018
• Device Model Number: 48008004S
• Device Catalogue Number: 48008004S
• Device Lot Number: 17326494
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 11/04/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/04/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/16/2016
• Supplement Report FDA Received Date: 12/01/2016; 12/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1