MAUDE Adverse Event Report: ST. JUDE MEDICAL INQUIRY ¿ STEERABLE DIAGNOSTIC CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	IBI-81531
Medical Device Problem Codes	Difficult to Remove (1528); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	10/22/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During the procedure, resistance was noted during device removal and bleeding was noted near the patient's groin.The catheter appeared damaged under fluoroscopy.The catheter was unable to be manipulated properly and could not be removed from the patient.Resistance was met near the groin area during removal so the introducer and catheter were removed together.Following removal, the catheter shaft was torn and the internal components were exposed.The patient was bleeding from the removal site and a d-stat was used to stop the bleeding.The patient was discharged in stable condition.
Additional Manufacturer Narrative
The reported deflection issue and catheter damage were confirmed.A tear was noted in the catheter shaft exposing the conductor wires.The catheter deflected when actuating the steering mechanism; however, the catheter did not deflect in the correct shape according to specifications, due to bends in the shaft, consistent with the reported withdrawal difficulty.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the bends and tear in the catheter shaft are consistent with damage during use.The cause of the patient bleeding may have been procedure related.

• Brand Name: INQUIRY ¿ STEERABLE DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 8064923
• Report Number: 3008452825-2018-00385
• Device Sequence Number: 11260445
• Product Code: DRF
• UDI-Device Identifier: 05414734304788
• UDI-Public: 05414734304788
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K961924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: IBI-81531
• Device Catalogue Number: IBI-81531
• Device Lot Number: 6445830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 11/18/2018; 01/24/2019
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 11/20/2018; 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Weight: 59