MAUDE Adverse Event Report: CORDIS DE MEXICO SABER 3MM30CM 90 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number 48003030S

Device Problem Detachment Of Device Component (1104)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 09/08/2017

Event Type  Injury  

Manufacturer Narrative

As reported, a 3 x 300 mm 90 cm saber balloon separated into two pieces during the procedure. The separated segment was retrieved with a snare. Another balloon was used to complete the procedure. The procedure was completed successfully without patient injury, however there was prolongation of the operating time. The vessel characteristics were unknown. The device was stored and handled per the instructions for use (ifu). There were no difficulties removing the product from the packaging, the stylet or any of the sterile packaging components, the product from the hoop, or the protective balloon cover. The product was inspected prior to use and appeared to be normal. The device was prepped properly according to the ifu and prepped normally (i. E. Maintain negative pressure). There were no kinks or other damages noted prior to inserting the product into the patient. Additional procedural details were requested but are unknown. The device was not returned for analysis. A device history record (dhr) review of lot 17556233 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 cause of the separation could not be determined. Based on the limited information available for review, vessel characteristics (although unknown) and handling factors may have contributed to the reported event as calcification/resistant lesions may cause damage to a balloon and handling of the balloon catheter after damage can lead to a separation. According to the instructions for use, which is not intended as a mitigation, ¿when the catheter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation. Do not advance or retract the catheter unless the balloon is fully deflated under vacuum. If resistance is met during manipulation, determine the cause of resistance before proceeding. 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. ¿ 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. (b)(4).

Event Description

As reported, a saber 3 mm x 30 cm 90 balloon separated into two pieces during the procedure. The device was stored and handled per the instructions for use (ifu). There were no difficulties removing the product from the packaging, the stylet or any of the sterile packaging components, the product from the hoop, or the protective balloon cover. The product was inspected prior to use and appeared to be normal. The device was prepped properly according to the ifu and prepped normally (i. E. Maintain negative pressure). There were no kinks or other damages noted prior to inserting the product into the patient. The separated segment was retrieved with a snare. Another balloon was used to complete the procedure. The procedure was completed successfully without patient injury, however there was prolongation of the operating time. Additional procedural details were requested but are unknown.

• Brand Name: SABER 3MM30CM 90
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 7057924
• MDR Text Key: 92881737
• Report Number: 9616099-2017-01614
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K971010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 48003030S
• Device Lot Number: 17556233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 08/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/24/2017 Patient Sequence Number: 1