MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) INTELLAMAP ORION¿; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M004RC64S0

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/24/2016

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 the device was removed in a fully deployed state.The treatment locations was the left atrium.An intellamap orion¿ catheter was used.During the procedure, the catheter was pulled back into the sheath while fully deployed."something didn't look right in the basket".The procedure was completed with another of the same device.No patient complications were reported and the patient's status is fine.

Manufacturer Narrative

Device evaluated by mfr: unit returned in a generic plastic bag.The unit returned has the distal end damaged , as part of overall visual revision.The returned device matches with upn provided by the customer.The device has kink 2 mm from the proximal end where the strain relief insulation meets the catheter shaft tubing.The deployment shaft is kinked and protrudes outside of undeployed array.The electrical test was performed and the device passed the test.The device failed the magnetic tracking test.The device failed the step for "magnetic registration."magnetic sensor resistance test was within specification.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that the device was removed in a fully deployed state.The treatment locations was the left atrium.An intellamap orion¿ catheter was used.During the procedure, the catheter was pulled back into the sheath while fully deployed."something didn't look right in the basket".The procedure was completed with another of the same device.No patient complications were reported and the patient's status is fine.

• Brand Name: INTELLAMAP ORION¿
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 6113919
• MDR Text Key: 60436493
• Report Number: 2134265-2016-10847
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122461
• 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: 10/24/2016

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 Model Number: M004RC64S0
• Device Catalogue Number: RC64S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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