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
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/28/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 7216383
• Report Number: 2134265-2018-00505
• Device Sequence Number: 11019886
• Product Code: DRF
• UDI-Device Identifier: 08714729877820
• UDI-Public: 08714729877820
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K992373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2018

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1