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	4808561
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that during port placement procedure, the port allegedly broke and guide wire fractured.It was further reported that broken pieces retained in svc/right atrium were removed from patient.The patient is in stable condition.
Event or Problem Description
It was reported that during port placement procedure, the fluoroscope demonstrated that the port allegedly broke and guide wire fractured.It was further reported that broken pieces retained in svc/right atrium were removed from the patient.Reportedly additional fluoroscope technique was used to remove the catheter from the patient.The patient is in stable condition.
Additional Manufacturer Narrative
H10: 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.H10: b5, d4 (expiry date: 06/2024), g3.H11: d1, d4(medical device lot), h6(patient).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 or Problem Description
It was reported that during port placement procedure, the fluoroscope demonstrated that the port allegedly broke and guide wire fractured.It was further reported that broken pieces retained in svc/right atrium were removed from the patient.Reportedly additional fluoroscope technique was used to remove the catheter from the patient.The patient is in stable condition.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the first complaint reported for this product/lot number combination.Therefore, a device history record review is not required.Investigation summary: one powerport mri isp, one groshong catheter, one flushing connector, one introducer needle, one straight non-coring needle, one right-angle non-coring needle, two catheter locks, one syringe, one guidewire and guidewire hoop, one vessel dilator, one safety infusion set, and one tunneler were returned for evaluation.Gross visual and microscopic visual evaluations were performed.The investigation is confirmed for the reported catheter fracture and the identified deformation and material separation issue, as a compound break was noted between the proximal, distal catheter segments, further the edges of the compound break were nonuniform and stylet had a kink.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: 06/2024), g3, h6 (device).H11: h6 (result, conclusion).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.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 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: 11341804
• Report Number: 3006260740-2021-00379
• Device Sequence Number: 610645
• Product Code: LJT
• UDI-Device Identifier: 00801741027352
• UDI-Public: (01)00801741027352
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2021

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: 4808561
• Device Catalogue Number: 4808561
• Device Lot Number: REER0645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 02/24/2021; 07/22/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/23/2021; 07/26/2021
• 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