MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER; ELECTRODE RECORDING CATHETER

Model Number	IBI-81532
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis; however, images were submitted for evaluation.The images appear to show that the catheter was knotted around the guidewire inside of the patient, consistent with the reported event.Visual inspection was based solely upon a review of the photographs received.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the knotted catheter and subsequent additional procedure remains unknown.
Event or Problem Description
During an atrial tachycardia ablation procedure the catheter became entangled with an introducer and additional surgery was required.Following the right femoral puncture the physician experienced difficulty inserting the diagnostic catheter into the patient's heart due to the loop shape of the catheter.Resistance was felt when removing the catheter for repositioning.An x-ray was performed and the catheter was in the shape of an 8 in the iliac and femoral vein.Following further repositioning the catheter became entangled with the introducer.The introducer broke and a fragment remained within the patient.Surgery was required to remove the catheter and remaining fragment of the introducer from the patient.The patient was stable.

• Brand Name: INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER
• Common Device Name: ELECTRODE RECORDING CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; 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: 7641299
• Report Number: 3008452825-2018-00193
• Device Sequence Number: 1861635
• Product Code: DRF
• UDI-Device Identifier: 05414734304795
• UDI-Public: 05414734304795
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K961924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2018

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: 11/30/2020
• Device Model Number: IBI-81532
• Device Catalogue Number: IBI-81532
• Device Lot Number: 6248687
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 06/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AVAIL QUADRAPOLAR CATHETER; BALTON INTRODUCERS X3
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR