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

Model Number 9808560

Device Problems Fracture (1260); Material Separation (1562); Dent in Material (2526); Misassembly by Users (3133); Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/13/2023

Event Type  Injury  

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.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.

Event Description

It was reported that approximately three years and eleven months post a port placement, computed tomographic examination revealed that the catheter was allegedly broken.It was further reported that approximately ten centimeters of the distal catheter segment remained in the right ventricle.Reportedly, the removal of the port body and the distal catheter segment will be considered in the future.There current status of the patient is unknown.

Event Description

It was reported that approximately three years and eleven months post a port placement, computed tomographic examination revealed that the catheter was allegedly broken.It was further reported that approximately ten centimeters of the distal catheter segment remained in the right ventricle.Reportedly, the removal of the port body and the distal catheter segment will be considered in the future.There current status of the patient is unknown.

Manufacturer Narrative

Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport isp mri implantable port attached to a groshong catheter was received for evaluation.Visual, microscopic, tactile and functional evaluations were performed.A complete circumferential break was noted at the distal end of the attached catheter that was elliptical in shape.The edges of the break was noted to be uneven and the surface were noted to be round and smooth in one region and granular in the other region.The distal catheter segment was not returned.The cath-lock was noted to be loaded backwards.Therefore, the investigation is confirmed for the reported fracture, material separation and the identified disassembled by user issues.However the investigation is inconclusive for the reported migration issues as no objective evidence was provided for review.The 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.The information provided 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.

Event Description

It was reported that approximately three years and eleven months post a port placement via right internal jugular vein, computed tomographic examination revealed that the catheter was allegedly broken.It was further reported that approximately ten centimeters of the distal catheter segment remained in the right ventricle.Reportedly, the device was removed.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport isp mri implantable port attached to a groshong catheter was received for evaluation.Visual, microscopic, tactile and functional evaluations were performed.A complete circumferential break was noted at the distal end of the attached catheter that was elliptical in shape.The edges of the break was noted to be uneven and the surface were noted to be round and smooth in one region and granular in the other region.The distal catheter segment was not returned.The cath-lock was noted to be loaded backwards.Therefore, the investigation is confirmed for the reported fracture, material separation and the identified misassembled by user issues.However the investigation is inconclusive for the reported migration issues as no objective evidence was provided for review.The 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 provided 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.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• Type of Device: 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16900856
• MDR Text Key: 314885409
• Report Number: 3006260740-2023-01787
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027512
• UDI-Public: (01)00801741027512
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2023

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: 9808560
• Device Catalogue Number: 9808560
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 07/27/2023; 08/01/2023
• Supplement Dates FDA Received: 07/27/2023; 08/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• 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: 50 YR
• Patient Sex: Female