MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV ACHIEVE MAPPING CATHETER - 20 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT

Model Number 990063-020

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Hemoptysis (1887); Hemorrhage/Bleeding (1888); Cardiac Perforation (2513)

Event Date 01/01/2022

Event Type  Injury  

Event Description

A journal article was reviewed that contained information regarding cryoballoon ablation.The article reports a patient who underwent an ablation procedure and contrast medium showed unnatural accumulation before cryothermal energy application; hence, the circular mapping catheter was removed from the right inferior pulmonary vein (ripv) and reinserted.Contrast medium was infected a second time to confirm the complete occlusion status.During the second contrast medium infusion into the ripv with complete cryoballoon occlusion, the angiography revealed unexpected contrast findings in the small upper ripv branch, and the patient experienced sudden massive hemoptysis and their oxygen saturation level had decreased.They performed an endotracheal intubation to secure the airway with a single-lumen tube, which was changed to a left-sided double-lumen tube.A bronchial blocker was inserted into the right lower lobe from the bronchial lumen to stop the bleeding.Medications were injected to reverse the anticoagulant.Computed tomography (ct) angiography revealed a massive pulmonary hemorrhage and contrast medium leakage into the right lower lobe.Three-dimensional ct showed a perforated small upper ripv branch.Endobronchial bleeding was persistent, and fresh blood filled the endotracheal tube.The patient underwent urgent thoracoscopic right lower lobectomy approximately six hours post catheter ablation.The macroscopic findings of the right lower lobe revealed a large, intrapulmonary hematoma.A ruptured pulmonary vein wall and pulmonary hemorrhage were observed with no ripv dissection, suggestive of mechanical injury without lodging.A micro perforation was confirmed.The status/disposition of the mapping catheter is unknown.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.This event occurred outside the us.Patient information is limited due to confidentiality concerns.The event only occurred with one patient but specific details on the patient were not provided.The model listed in the report is a representative of the model family, as there is no specific model listed.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: pulmonary vein perforation and life-threatening hemoptysis during cryoballoon ablation for persistent atrial fibrillation.Journal of the american college of cardiology: case reports.2022.Vol.4, no.7; 418-423.Doi:10.1016/j.Jaccas.2021.11.026.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACHIEVE MAPPING CATHETER - 20 MM
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECT
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14211734
• MDR Text Key: 290097236
• Report Number: 9617601-2022-00060
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2022

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
• Device Operator: Health Professional
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 04/26/2022
• 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
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 73 KG