MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	7757540
Medical Device Problem Codes	Difficult to Flush (1251); Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/08/2017
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 not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Medical device - expiry date: 09/2017.
Event or Problem Description
It was reported that approximately 4 years 7 months post port placement, the port allegedly stopped flushing.It was further reported that additional surgery was conducted to remove the port.Reportedly during removal procedure, the catheter allegedly broken, the proximal end of the catheter was retracted with the tip of the catheter being obtained.The procedure was completed using another device.Patient status was unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the sample was not returned for evaluation, however, one medical record was provided for review.The investigation is confirmed for the reported fracture and flushing issue.Per the medical record, the port was placed on a patient due to leukemia who required port for chemotherapy.The proximal end of the catheter was cut to length and affixed to the port.The port (lot no# rewh0932) was positioned in the pocket.The port was accessed through the skin, subcutaneous and subcuticular sutures were placed.Approximately four years and six months post port deployment, the patient presented with malfunctioning mediport.Subsequently an attempt was made to remove the mediport and replace with new mediport.Attempts were made to access the subclavian vein with an 18-gauge needle, but this was unsuccessful.Later, through the left internal jugular vein, a new port was placed.Eventually, attention was then turned to remove the old port.The incision over the tunnel at the site of the catheter breakage was anesthetized, incision was made over this.The catheter was then dissected free.The proximal end of the catheter was retracted with the tip of the catheter being obtained.The proximal end was trimmed off the old port, pocket incision was then opened and the catheter was dissected out and this was passed.The port, remaining piece of the catheter was passed off as a unit.These incisions were then closed with subcuticular stitches.The patient was awakened and moved to the recovery room in satisfactory condition.A definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11: section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.
Event or Problem Description
It was reported through the litigation process that approximately four years and seven months post port placement, the port allegedly stopped flushing.It was further reported that additional surgery was conducted to remove the port.Reportedly during removal procedure, the catheter was allegedly broken and the proximal end of the catheter was retracted with the tip of the catheter being obtained.The procedure was completed using another device.Patient status was unknown.

• Brand Name: X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 8F
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11670562
• Report Number: 3006260740-2021-01314
• Device Sequence Number: 2999079
• Product Code: LJT
• UDI-Device Identifier: 00801741027505
• UDI-Public: (01)00801741027505
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K022983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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: 7757540
• Device Catalogue Number: 7757540
• Device Lot Number: REWH0932
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 06/10/2021
• 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: 50 YR