MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. INQUIRY¿ ELECTROPHYSIOLOGY CATHETER, INQUIRY¿ AFOCUS II¿ EB CATHETER, 110 CM LEN; ELECTRODE RECORDING CATHETER

Model Number D087023

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2018

Event Type  malfunction  

Event Description

Upon removal of the catheter from the sheath, the tip of the catheter broke inside the sheath.When the mapping catheter was advanced into the sheath, the tip of the catheter became lodged in the sheath.When attempting to remove the catheter, the tip broke inside the sheath.Another device was used to continue the procedure with no consequences to patient.

Manufacturer Narrative

One inquiry steerable afocusii catheter was received for evaluation.Visual inspection revealed multiple bends in the catheter and electrode one was not present and the conductor wires were exposed.Further investigation revealed electrode one had been displaced and was free within the sheath.The displaced electrode is consistent with the electrode ring getting caught on the introducer sheath during the procedure.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the displaced electrode is consistent with damage during use.

• Brand Name: INQUIRY¿ ELECTROPHYSIOLOGY CATHETER, INQUIRY¿ AFOCUS II¿ EB CATHETER, 110 CM LEN
• Type of Device: ELECTRODE RECORDING CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 2375 morse ave; irvine CA 92614
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7467862
• MDR Text Key: 106742978
• Report Number: 2030404-2018-00032
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K042775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: D087023
• Device Lot Number: 6049811
• Other Device ID Number: 05414734311434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/27/2018
• Supplement Dates Manufacturer Received: 06/13/2018
• Supplement Dates FDA Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2017
• 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