MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MRI HARD B ATT OPEN 6.6; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 0604580

Device Problem Break (1069)

Patient Problem Pulmonary Embolism (1498)

Event Date 03/14/2019

Event Type  Injury  

Manufacturer Narrative

The lot number for the device was provided.The device history records are currently under review.The device is not available for return.The investigation is currently underway.

Event Description

It was reported that after three years of device placement in the subclavian vein, an image examination was performed and an alleged catheter break was identified close to the right clavicle.It was further reported that the catheter embolized to the pulmonary artery requiring a two different procedures for catheterization, port removal by surgery, and a new device placement.Reportedly, the patient is under healing measures.

Manufacturer Narrative

Manufacturer review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one catheter segment measuring approximately 17.7cm in length was returned for evaluation.Visual, microscopic and functional evaluations were performed.The investigation is confirmed for catheter break with embolism, as the proximal end of the catheter appeared to have been cut and was slightly uneven.The distal end of the catheter was jagged from a complete break in the catheter.Catheter tip was not returned.However, the definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural issues contributed to the reported event.Possible contributing factors include pinch off, flexural fatigue, and over-pressurization.Labeling review: a review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.

Event Description

It was reported that after three years of device placement in the subclavian vein, an image examination was performed and an alleged catheter break was identified close to the right clavicle.It was further reported that the catheter embolized to the pulmonary artery requiring a two different procedures for catheterization, port removal by surgery, and a new device placement.Reportedly, the patient is under healing measures.

• Brand Name: MRI HARD B ATT OPEN 6.6
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8576011
• MDR Text Key: 143934496
• Report Number: 3006260740-2019-01270
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025877
• UDI-Public: (01)00801741025877
• Combination Product (y/n): N
• PMA/PMN Number: K873213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 08/02/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 0604580
• Device Catalogue Number: 0604580
• Device Lot Number: REXG1517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 05/02/2019
• Supplement Dates Manufacturer Received: 07/18/2019
• Supplement Dates FDA Received: 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR