MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) ORBITER¿ ST BIDIRECTIONAL STEERABLE DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M0043200070

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Date 09/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device was returned for analysis.There was a bent pin in the connector.The od (outer diameter) of the insulation at the proximal end of the tip was larger than the od of the tip itself.There were three gaps in the adhesive between the tip and the catheter shaft insulation, seen at 12.5x magnification.There was a crease in the insulation at each hole in the adhesive.The creases are discolored (white) and approximately 1mm long.This device was a 7fr device.The shaft did not fit through the 7fr gauges.The shaft did not pass through the 7.25fr gauge.Measurements of the tip and shaft were taken, the tip od, shaft between r1/r2 and r2/r3 were within specification.Shaft proximal to tip and distal to ring 1 was above specifications.The shaft length was within specification.The gap between the proximal end of the tip and the distal end of e2 is approximately 2cm.X-rays of the distal tip did not reveal any abnormalities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

Reportable based on device analysis completed on (b)(6) 2018.It was reported that the device had bent pins in the connector.During preparation for an ablation procedure with an orbiter st bidirectional steerable diagnostic catheter, the device would not connect to the cable.The device had bent pins.No patient complications occurred as the device did not enter the patient.Device analysis revealed three gaps in the adhesive between the tip and the catheter shaft insulation.

• Brand Name: ORBITER¿ ST BIDIRECTIONAL 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: 7216383
• MDR Text Key: 98165377
• Report Number: 2134265-2018-00505
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729877820
• UDI-Public: 08714729877820
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2020
• Device Model Number: M0043200070
• Device Catalogue Number: 320007
• Device Lot Number: 0020169863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2017
• 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