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 Fluid/Blood Leak (1250); Fracture (1260); Material Fragmentation (1261); Material Twisted/Bent (2981); Migration (4003)

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

Event Date 07/13/2022

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records was performed.The device has been returned to the manufacturer for evaluation as well as images were provided for review.The investigation of the reported event is currently underway.(expiration date: 04/2023).

Event Description

It was reported that approximately two years post port placement, swelling and pain occurred near port site.It was further reported that the catheter allegedly had a crack and saline solution allegedly leaked from the cracked site.Reportedly, port was removed.There was no reported patient injury.

Event Description

It was reported that approximately two years post port placement, swelling and pain occurred near port site.It was further reported that the catheter allegedly had a crack and saline solution allegedly leaked from the cracked site.Reportedly, port was removed.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: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one powerport isp mri attached to a groshong catheter was returned.Gross, microscopic visual, tactile evaluation and functional testing were performed.In addition to the returned physical three radiographic images were provided for review.The x-ray image shows a right sided chest wall port and the catheter in the was appeared to have twisted and migrated proximally.The port also appears more medial in the chest.Further, near the right clavicle there may be a fracture or defect in the catheter.Therefore, the investigation is confirmed for the reported fracture and fluid leak and identified catheter twist, fragmentation and migration issues as two partial circumferential breaks were noted approximately 6.3cm and 7.0cm from the distal end of the cath-lock.Under microscopic observation, a small portion of the outer catheter was noted to be missing.The edges of both the partial circumferential break on the catheter was noted to be uneven and the surfaces were noted to be granular.Upon infusion, leaks were observed from the partial circumferential breaks on the catheter.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 (expiration date: 04/2023), g3, h6 (device, 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.

• 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: 15391217
• MDR Text Key: 299707918
• Report Number: 3006260740-2022-03540
• 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
• Report Date: 11/03/2022

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
• Device Operator: Health Professional
• Device Model Number: 9808560
• Device Catalogue Number: 9808560
• Device Lot Number: REEU1246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2022
• Initial Date FDA Received: 09/09/2022
• Supplement Dates Manufacturer Received: 11/03/2022
• Supplement Dates FDA Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2020
• 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: 80 YR