MAUDE Adverse Event Report: CORDIS CASHEL SABER 3MM4CM 150; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	48003004X
Medical Device Problem Codes	Burst Container or Vessel (1074); Physical Resistance (2578); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that there was resistance felt advancing a saber balloon catheter to the lesion and through the guiding catheter.The saber balloon ruptured at its nominal pressure.Therefore the balloon catheter was replaced with a new unknown balloon catheter and the procedure completed successfully.There was no reported patient injury.The target lesion was the superficial femoral artery.The patient¿s vessel was not tortuous and moderately calcified.The rate of stenosis was 100 % chronic total occlusion (cto).A contralateral approach was made and a saber balloon was inserted for back-up, however there was resistance felt while advancing to the lesion.When it was inflated as a pre-dilatation, it ruptured.The device was prep normally.There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.The product was removed intact (in one piece) from the patient.The device was not returned for analysis.A device history record (dhr) review of lot 17094144 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿pta/ptca system tracking difficulty,¿ ¿pta/ptca system resistance/friction-outer body,¿ and ¿balloon burst - at/below rbp¿ could not be confirmed as the device was not returned for analysis.The exact cause of the events reported could not be determined.Based on the limited information available, vessel characteristics likely contributed to the tracking difficulty and resistance/friction reported.Difficulty tracking a product through an anatomical structure is a known procedural occurrence.This type of difficulty occurring during the clinical use of the device is usually addressed by modification in technique or substitution with another device.Tracking difficulty is most commonly related to the patient¿s anatomy, vessel characteristics, operator¿s technique and appropriate device selection.Interference or friction between devices, (including all catheters, wires, sheath introducers, balloon/sds catheters) whether between one or multiple manufacturers product lines, is a known occurrence.If resistance is encountered the system should be withdrawn together as one unit to prevent injury.This is a common practice during procedures and is stated in product¿s ifu.Based on the limited information available for review, lesion characteristics (moderately calcified cto) and procedural factors (difficulty tracking to the lesion) likely contributed to the reported balloon burst as calcification/resistant lesions may cause damage to a balloon.According to the instructions for use, which is not intended as a mitigation, ¿the rated burst pressure is based on the results of in vitro testing.At least 99.9% of the balloons (with a 95% confidence) will not burst at or below their rated burst pressure.Use of a pressure monitoring device is recommended to prevent over-pressurization.Do not exceed the rated burst pressure recommended on the label.Prior to angioplasty, the catheter should be examined to verify functionality and ensure that its size and shape are suitable for the specific procedure for which it is to be used.¿ 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 at this time.
Event or Problem Description
It was reported that there was resistance felt advancing a saber balloon catheter to the lesion and through the guiding catheter.The saber balloon ruptured at its nominal pressure.Therefore the balloon catheter was replaced with a new unknown balloon catheter and the procedure completed successfully.There was no reported patient injury.A contralateral approach was made and a saber balloon was inserted for back-up, however there was resistance felt while advancing to the lesion.When it was inflated as a pre-dilatation, it ruptured.The target lesion was the superficial femoral artery.The patient¿s vessel was not tortuous and moderately calcified.The rate of stenosis was 100 % (cto).The device was prep normally.There were no difficulties removing the product from the hoop, the protective balloon cover, the stylet or any of the sterile packaging components.There were no kinks or other damages noted prior to inserting the product the product into the patient.The product was removed intact (in one piece) from the patient. the product was clinically used and will not be returned for analysis.

• Brand Name: SABER 3MM4CM 150
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel, tipperary 32575 ; EI 32575
• MDR Report Key: 6757448
• Report Number: 9616099-2017-01281
• Device Sequence Number: 1038768
• Product Code: LIT
• UDI-Device Identifier: 20705032069097
• UDI-Public: 20705032069097
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 08/01/2017

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: 07/31/2017
• Device Model Number: 48003004X
• Device Catalogue Number: 48003004X
• Device Lot Number: 17094144
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 08/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1