MAUDE Adverse Event Report: MEDTRONIC IRELAND FLEXCATH CONTOUR¿ STEERABLE SHEATH; CATHETER, STEERABLE

Model Number	10FCC13
Medical Device Problem Codes	Peeled/Delaminated (1454); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during a cardiac ablation procedure, the provider observed a long, narrow "string" of what appeared to be plastic removed from the sheath after extracting the catheter.Subsequently, the catheter and sheath were replaced along with another manufacturer's wire.There was also a cable connection issue wherein catheter interface cable (cic) and catheter distortion were noted on the mapping system.Troubleshooting included unplugging and re-plugging the cic multiple times at both the catheter and generator, and a new respiratory was obtained using the another manufacturer's mapping system.The cic was replaced to resolve the distortion.The case was completed.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: product id: pscic101 product type: catheter interface cable correction: d10/h11 - concomitant product added.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Product event summary: the 10fcc13 sheath with lot number 0012816920 was returned and analyzed.Visual inspection before functional testing and dissection was performed on the shaft, handle, and dilator.No anomaly was identified during the external visual inspection.All the handle, shaft and sideport were intact with no apparent issue.The functional testing was performed.No anomaly was discovered.The steering mechanism and deflection tests were completed successfully.Primary deflection at 90° and 180°, as well as secondary deflection at 90°, were achieved without any issues.The mechanism operated smoothly, with no friction, resistance, or unusual noise.Borescope inspection of the sheath revealed delamination of the ptfe sheath liner at 10.5 inches (in), 12.5 in, and 20 in, as well as inside the handle and at the tip of the sheath.In conclusion, the reported strings of plastic were confirmed through analysis.The sheath failed the returned product inspection due to the delaminated ptfe sheath liner.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: FLEXCATH CONTOUR¿ STEERABLE SHEATH
• Common Device Name: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24280256
• Report Number: 9612164-2026-00678
• Device Sequence Number: 13243614
• Product Code: DRA
• UDI-Device Identifier: 00763000659080
• UDI-Public: (01)00763000659080(17)270519(10)0012816920(20)01
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K232321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/16/2026

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
• Operator of Device: Health Professional
• Device Model Number: 10FCC13
• Device Catalogue Number: 10FCC13
• Device Lot Number: 0012816920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 02/06/2026; 02/16/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 02/06/2026; 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRODUCT ID: PSCC100, PRODUCT TYPE: CATHETER; SEE H11...
• Patient Age: 58 YR
• Patient Sex: Female