MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) EP¿XT¿ UNIDIRECTIONAL STEERABLE DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M0042007940

Device Problem Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been received 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

It was reported that inner package damage occurred.A 110cm ep¿xt¿ unidirectional steerable diagnostic catheter was selected for use.When the device was received, it was noted that the inner package and the catheter were damaged and unable to be used.The device was not used in a procedure.No patient complications reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Inspection shows the unit was returned with its original box which was opened, however the plastic package which contains the catheter was unopened.The package has multiple bends along the box on both sides, near the lower (distal tip) section.The bends are visible on the catheter in the same location as the outer box.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported that inner package damage occurred.A 110cm ep¿xt¿ unidirectional steerable diagnostic catheter was selected for use.When the device was received, it was noted that the inner package and the catheter were damaged and unable to be used.The device was not used in a procedure.No patient complications reported.

• Brand Name: EP¿XT¿ UNIDIRECTIONAL STEERABLE DIAGNOSTIC CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6659960
• MDR Text Key: 78183012
• Report Number: 2134265-2017-06352
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K921872A
• 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
• Report Date: 06/07/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 03/08/2020
• Device Model Number: M0042007940
• Device Catalogue Number: 200794
• Device Lot Number: 0020385734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2017
• Initial Date FDA Received: 06/22/2017
• Supplement Dates Manufacturer Received: 06/29/2017
• Supplement Dates FDA Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1