MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) ULTRA ICE PLUS¿; CATHETER, ULTRASOUND, INTRACARDIAC

Model Number M00499120

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as: 2134265-2017-05583.It was reported that tip detachment occurred.An ultra ice¿ diagnostic catheter was selected for use.During the procedure, the physician used the first ultra ice¿, however, it was noticed that the tip of ultra ice¿ was detached after long use and the catheter stopped spinning.Another ultra ice¿ was used but the same issue occurred.The procedure was completed with using the third ultra ice¿ diagnostic catheter.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Device analysis revealed that the transducer distal housing was found detached from the drive cable.Evidence of the 6 weld points found in the distal housing and drive cable.All the diameter measurements are within the specifications.It was observed that the catheter flushed normally.Impedance testing shows an electrical open at distal wave form.Full image characterization cannot be performed due to detachment.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

Same case as: 2134265-2017-05583.It was reported that tip detachment occurred.An ultra ice¿ diagnostic catheter was selected for use.During the procedure, the physician used the first ultra ice¿, however, it was noticed that the tip of ultra ice¿ was detached after long use and the catheter stopped spinning.Another ultra ice¿ was used but the same issue occurred.The procedure was completed with using the third ultra ice¿ diagnostic catheter.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Updated: ae or product problem from reported issue is both an adverse event and product problem to product problem.Updated: type of reportable event from serious injury to malfunction.Updated: describe event or problem.(b)(4).

Event Description

It was further reported that the tip detaches within the catheter housing.It doesn't actually detach itself into the patient.The catheter itself remains intact.There was/is an issue with the weld at the tip point.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the tip detaches within the catheter housing.It doesn't actually detach itself into the patient.The catheter itself remains intact.There was/is an issue with the weld at the tip point.

• Brand Name: ULTRA ICE PLUS¿
• Type of Device: CATHETER, ULTRASOUND, INTRACARDIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6614397
• MDR Text Key: 76745524
• Report Number: 2134265-2017-05584
• Device Sequence Number: 1
• Product Code: DXK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2019
• Device Model Number: M00499120
• Device Catalogue Number: 9912
• Device Lot Number: 20268633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other