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); Deformation Due to Compressive Stress (2889); Naturally Worn (2988); Migration (4003)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2022

Event Type  Injury  

Event Description

It was reported that approximately three years and six months post port placement via the right internal jugular vein, the catheter break was allegedly found under ct examination.It was further reported that the port body and the distal catheter segment were removed percutaneously.There was no reported patient injury.

Manufacturer Narrative

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.

Manufacturer Narrative

H10: additional information was received and the file was reassessed for reportability and determined to be reportable as serious injury.H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 Description

It was reported that approximately three years and six months post port placement via the right internal jugular vein, the catheter break was allegedly found under ct examination.It was further reported that the port body and the distal catheter segment were removed percutaneously.Reportedly, the catheter migrate inside the patient.The current status of the patient is unknown.

Event Description

It was reported that approximately three years and six months post port placement via the right internal jugular vein, the catheter break was allegedly found under ct examination.It was further reported that the port body and the distal catheter segment were removed percutaneously.Reportedly, the catheter migrate inside the patient.The current status of the patient is unknown.

Manufacturer Narrative

H10: additional information was received and the file was reassessed for reportability and determined to be reportable as serious injury.H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport mri isp implantable, one cath-lock and a groshong catheter in two segments were returned for evaluation.Gross, microscopic visual, tactile, dimensional evaluation and functional testing were performed.The investigation is inconclusive for the reported migration issue as the exact circumstances at the time of the reported event are unknown and clinical conditions cannot be replicated to confirm these failures.However, the investigation is confirmed for the reported catheter fracture, material separation and identified deformation and wear issues as a partial c-shaped break was noted on the catheter approximately 6.9cm from the proximal end of the proximal end of the catheter returned.A complete circumferential breaks were noted on the distal end of the proximal end of the catheter returned and the proximal end of the distal catheter segment.Further, two longitudinal splits were noted approximately 1.0cm and 1.5cm from the proximal end of the distal catheter segment.The edges of the proximal end of the catheter returned was noted to be round.Also, the edges of the complete circumferential break on the distal end of the catheter and proximal end of the distal catheter segment were noted to be jagged and the surfaces were noted to be round in one region and granular in the other region.Upon infusion, a leak was noted from splits on the proximal end of the catheter and the proximal c-shape break proximal to the distal end of the catheter.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.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 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.

• 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: 15127694
• MDR Text Key: 302334931
• Report Number: 3006260740-2022-02945
• 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: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• 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
• Date Manufacturer Received: 09/19/2022
• 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 Sex: Female
• Patient Weight: 46 KG