MAUDE Adverse Event Report: MPRI BROCKENBROUGH¿ NEEDLE; TROCAR

Model Number EP003994S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Death (1802)

Event Date 07/05/2019

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: mapping catheter, 990045 guide wire, 990061-070 sheath.Product event summary: the data files were returned however they were corrupted and unable to be opened.The clinical issues reported would not have been confirmed through the data files.The physical product was not returned for investigation.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that immediately after a successful cryo ablation procedure, the patient experienced bradycardia.The patient was then paced.A cardiac massage and pericardiocentesis were performed and two hours of pharmacological treatments were administered.The patient is deceased.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was further reported the physician noted the patient "probably had a coronaropathy "by stander" and the death was caused by electromechanical dissociation.".

• Brand Name: BROCKENBROUGH¿ NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8842359
• MDR Text Key: 152677358
• Report Number: 2649622-2019-13371
• Device Sequence Number: 1
• Product Code: DRC
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EP003994S
• Device Catalogue Number: EP003994S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: 2AF283 BALLOON CATHETER, 4FC12 SHEATH, 2ACH20
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Weight: 77