MAUDE Adverse Event Report: COOK INC UNKNOWN; DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number N/A

Device Problems Other (for use when an appropriate device code cannot be identified) (2203); Appropriate Term/Code Not Available (3191)

Patient Problems Heart Failure (2206); Surgical procedure, additional (2564); Blood pressure, decreased (2569)

Event Type  Injury  

Event Description

During a lead extraction procedure through the right ventricle on a (b)(6) patient, the byrd dilator sheath stopped between the atrium and/or ventricle where complications occurred.The physician decided to use a 13fr lead extractor.The lead was in place for 24 years and was ingrown at the ventricle.Afterwards, the physician saw that the lead was laying very deep at the septum and it was ingrown at a length around 4 cm.After extracting the lead, pressure drops down slowly but consistent.After checking the ventricle, the physician detects a perforation and a pericardial effusion.During drainage, the blood of the patient clotted immediately and the procedure was stopped.A surgeon was called in to open the chest, because patient heart functions stopped.Surgeons opened the chest and the physician squeezed the heart by hand until the life support machine was started.They detected a tear with a length of 3cm which was patched by the surgeon.After shutting down the lift support machine, the patient awoke two days after anesthesia.The patient left the hospital after three weeks without any damage reported.According to the physician, he is not sure if the event was related to the devices.

Manufacturer Narrative

This event is currently under investigaiton.

Manufacturer Narrative

The exact date was not provided.Reporter states the event occurred at the beginning of (b)(6).(b)(4).Event evaluation: a review of complaint history was conducted during the investigation.The device was not returned to assist in the investigation.No images were provided, the device model was not specified, and no lot number was returned.No information was provided that indicates a cook device malfunctioned or was not manufactured to specification.The complaint description indicated that a drop in blood pressure was observed, due to a perforation in a blood vessel.These are both known complications to the lead extraction procedure and are documented in the device failure mode, effects, and criticality analysis for these devices.The event resulted in significant harm to the patient resulting in hospitalization.There is no evidence to suggest the product was not manufactured to specification.There is no evidence to suggest nonconforming/defective product remains in house or in the field.A tear was observed in a blood vessel, but no evidence was found to suggest it was due to a device nonconformity or misuse.A quality engineering risk assessment was performed.Risk reduction activities are not required due to the occurrence.

Event Description

During a lead extraction procedure through the right ventricle on a (b)(6) year old male patient, another manufacturer's dilator sheath stopped between the atrium and/ or ventricle; where complications occurred.The physician decided to use a 13 fr lead extractor.The lead was in place for 24 years and was ingrown at the ventricle.Afterwards, the physician saw that the lead was laying very deep at the septum and it was ingrown at a length around 4 cm.After extracting the lead, pressure drops down slowly but consistent.After checking the ventricle, the physician detects a perforation and a pericardial effusion.During drainage, the blood of the patient clotted immediately and the procedure was stopped.A surgeon was called in to open the chest, because patient heart functions stopped.Surgeons opened the chest and the physician squeezed the heart by hand until the life support machine was started.They detected a tear with a length of 3cm; which was patched by the surgeon.After shutting down the life support machine, the patient awoke two days after anesthesia.The patient left the hospital after three weeks without any damage reported.According to the physician, he is not sure if the event was related to the devices.

• Brand Name: UNKNOWN
• Type of Device: DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4909646
• MDR Text Key: 21191723
• Report Number: 1820334-2015-00432
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: NA
• Event Location: Hospital
• Date Manufacturer Received: 06/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR