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

Model Number	1808561
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a port placement procedure in the right internal jugular vein, the catheter allegedly fractured and the catheter migrated from superior vena cava right atrium to catheter tip in right atrium with fractured end of catheter tip to left brachiocephalic vein.It was further reported that the catheter was removed from the patient using a gooseneck snare via an additional access site through right common femoral vein.The patient reported to be stable.
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.(expiry date: 01/2025).
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one groshong catheter in two segments were returned for evaluation and two electronic photos were provided for review.Gross visual, microscopic visual, tactile and functional evaluations were performed on the returned device.The investigation is confirmed for the reported fracture and material separation issues as a complete compound break was noted on the returned catheter and a split was noted approximately 1.2cm from the proximal end of the second catheter segment.The edges of the complete compound break were noted to be uneven and the surface was observed to be granular and glossy.During functional evaluation, a leak from the split was noted upon infusing the second catheter segment.However, the investigation is inconclusive for the reported migration issue as the exact circumstances at the time of the reported event cannot be verified.A definitive root cause could not be determined based upon the 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.H10: d4 (expiry date: 01/2025), g3, h6 (method).H11:section a through f - the information provided by bd represents all of 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.
Event or Problem Description
It was reported that during a port placement procedure in the right internal jugular vein, the device allegedly broke and the catheter migrated from superior vena cava right atrium to catheter tip in right atrium with fractured end of catheter tip to left brachiocephalic vein.It was further reported that the device removed from the patient using snare via additional access site right common femoral vein.The reported to be stable.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT WITH ATTACHABLE 8F GROSHONG SINGLE-LUMEN
• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13758231
• Report Number: 3006260740-2022-00792
• Device Sequence Number: 2383060
• Product Code: LJT
• UDI-Device Identifier: 00801741027123
• UDI-Public: (01)00801741027123
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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: 1808561
• Device Catalogue Number: 1808561
• Device Lot Number: REFW5049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 04/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown