MAUDE Adverse Event Report: ST. JUDE MEDICAL VIEWFLEX¿ XTRA ICE CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number D087031

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2019

Event Type  Injury  

Manufacturer Narrative

Further information regarding the event were requested but not received.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During an atrial tachycardia ablation procedure, there were insertion difficulties with the viewflex catheter.The catheter was removed and the physician touched the distal tip and the device was damaged.It was also noted the catheter did not possess hydrophobic characteristics.A non-abbott ice catheter was attempted to be used, however the adapter cable could not be located.The procedure was cancelled with no patient consequences.

Manufacturer Narrative

One viewflex¿ xtra ice catheter was received for investigation.The reported damage was confirmed however, the insertion difficulty was unable to be confirmed due to the condition of the returned device.The catheter shaft was bent and fractured at the tip.The catheter was recognized by the catheter interface module and zonare viewmate system, however functional testing was not possible due to the aforementioned damage.The cause of the damage is consistent with damage during use however; the cause of the insertion difficulty remains unknown.

• Brand Name: VIEWFLEX¿ XTRA ICE CATHETER
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): ST. JUDE MEDICAL; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• MDR Report Key: 8767404
• MDR Text Key: 150263911
• Report Number: 3008452825-2019-00323
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 05415067002082
• UDI-Public: 05415067002082
• Combination Product (y/n): N
• PMA/PMN Number: K133853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: D087031
• Device Lot Number: 6917436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 127