MAUDE Adverse Event Report: MEDTRONIC VASCULAR CATHETER CONNECTING CABLE; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT

Model Number	2ACHC
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id:2achc product type: cable; product id:2achc product type: cable; product id:2achc product type: cable.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 while setting up materials for a procedure, the inner packaging of the achieve cable was found to be already opened.This issue was identified with four cables.The cables were replaced to resolve the issue.There was no patient involved.
Additional Manufacturer Narrative
Product event summary: the 2achc mapping catheter cable of lot number g24a07188 was returned and analyzed.The mapping catheter cable was visually inspected.During external visual inspection of the retuned product and its original packaging, the seal was torn/compromised.The pouch containing the received cable was found with the original seal compromised and resecured using clear adhesive tape.In conclusion, the reported package sterile barrier compromised issue was confirmed and the packaging was observed to be not sealed.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: additional analysis was performed on the 2achc mapping catheter cable with lot number g24a07188.Further analysis was performed to examine the pouch seals.Using a high-magnification optical 20x microscope, the top, left, and right seals were inspected.The top seal was found to be partially open at the center portion of its length.The demarcation of the peeled-off top web seal left a white residue mark on the transparent film side of the pouch, that appeared irregular.The seal mark was not uniform and contained transparent spots.In comparison, the remaining portion of the top seal mark which was intentionally peeled in the lab, exhibited a better uniformity but still showed irregular edges.Inspection of the right-side and the left-side seal marks that were intentionally peeled in the lab, exhibited a well-defined edge with residue that was uniform along the entire seal.In conclusion, the reported package sterile barrier compromised issue was confirmed and the packaging was observed to be not sealed.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: CATHETER CONNECTING CABLE
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT
• Manufacturer (Section D): MEDTRONIC VASCULAR; 37a cherry hill dr; danvers,ma MN 55112
• Manufacturer (Section G): MEDTRONIC VASCULAR; 37a cherry hill dr; danvers,ma MN 55112
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 22149024
• Report Number: 2182208-2025-02751
• Device Sequence Number: 8469196
• Product Code: DRF
• UDI-Device Identifier: 00763000280024
• UDI-Public: (01)00763000280024(17)261022(10)G24A07188
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K153139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2025

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: 2ACHC
• Device Catalogue Number: 2ACHC
• Device Lot Number: G24A07188
• 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: 05/15/2025
• Supplement Date Received by Manufacturer: 06/16/2025; 09/11/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 07/11/2025; 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown