MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PPCVISP8FSCPOLYINT; IMPLANTABLE PORT

Model Number	1608362
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Medical device: expiration date: 12/2018.
Event or Problem Description
It was reported that upon removal of a port device, the port catheter was found allegedly broken with a segment of the port catheter remaining in cuff of the port body.It was further reported that the broken catheter segment migrated to the right ventricle.Reportedly, both segments were removed.There was no report of patient status post removal.
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was performed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: one clearvue isp port and polyurethane catheter were returned.A visual and tactile evaluation was performed.The sample was retuend in two segments.The catheter was noted to be broken just distal to the port stem.A small segment of catheter remained assembled under the cath-lock on the port stem.The depth markers were observed worn above depth marker 38.The break surface was observed to be a combination of smooth and rough textures, with some visible striations.Nothing remarkable was observed during tactile evaluation.Therefore, the investigation is confirmed for a broken catheter, specifically for a break at the stem.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.Labeling review: a review of the product instructions for use (ifu) procedural instructions, indications, warnings, precautions, cautions, possible complications and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that upon removal of a port device, the port catheter was found allegedly broken with a segment of the port catheter remaining in cuff of the port body.It was further reported that the broken catheter segment migrated to the right ventricle.Reportedly, both segments were removed.There was no report of patient status post removal.

• Brand Name: PPCVISP8FSCPOLYINT
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8462757
• Report Number: 3006260740-2019-00718
• Device Sequence Number: 2989153
• Product Code: LJT
• UDI-Device Identifier: 00801741108082
• UDI-Public: (01)00801741108082
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K150514
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2019

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
• Operator of Device: Health Professional
• Device Model Number: 1608362
• Device Catalogue Number: 1608362
• Device Lot Number: REBW0478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 04/27/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 05/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Weight: 59