MAUDE Adverse Event Report: CORDIS DE MEXICO SABER 5MM4CM 90; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48005004S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis.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 a saber pta balloon would not inflate.After three times of attempts, a leakage was confirmed at the joint of the hub and the shaft.Therefore it was replaced with a new saber pta.The procedure finished successfully.There was no reported patient injury.The saber was inflated by an indeflator.The target lesion was unknown.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.The product was not clinically used and it will not be returned for analysis.
Additional Manufacturer Narrative
It was reported that a 5x40mm saber pta balloon would not inflate.After three times of attempts, a leakage was confirmed at the joint of the hub and the shaft.Therefore it was replaced with a new saber pta.The procedure finished successfully.There was no reported patient injury.The saber was inflated by an indeflator.The target lesion was unknown.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.The device was not returned for analysis.A device history record (dhr) review of lot 17312808 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿luer hub leakage¿ and ¿body/shaft leakage¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Based on the limited information available for review, it is not possible to determine what factors may have contributed to this issue; however, procedural factors are likely.According to the instructions for use (ifu), ¿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.Neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken.

• Brand Name: SABER 5MM4CM 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: 6202164
• Report Number: 9616099-2016-00811
• Device Sequence Number: 755776
• Product Code: LIT
• UDI-Device Identifier: 20705032068649
• UDI-Public: 20705032068649
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 01/27/2017

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: 05/31/2019
• Device Model Number: 48005004S
• Device Catalogue Number: 48005004S
• Device Lot Number: 17521203
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 11/28/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2016
• Supplement Report FDA Received Date: 01/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1