MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 M.R.I. LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 7F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0603870
Medical Device Problem Codes	Fracture (1260); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/15/2022
Type of Reportable Event	Serious Injury
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 not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2026).
Event or Problem Description
It was reported that during a port placement procedure, the catheter and sheath allegedly ruptured.It was further reported that catheter allegedly failed to advance.The tear was noted in the right subclavian vein and experienced bleeding.The current status of the patient was reported to be stable.
Event or Problem Description
It was reported that during a port placement procedure, the catheter and sheath allegedly ruptured.It was further reported that catheter allegedly failed to advance.The tear was noted in the right subclavian vein and experienced bleeding.The current status of the patient was reported to be stable.
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 l/p mri implantable port attached to a groshong catheter, one 7.0fr peel-apart sheath, one vessel dilator and one catheter were returned for evaluation.Functional, gross visual, tactile, and microscopic visual evaluations were performed.A complete circumferential break was noted on the distal end of the catheter.However, striations were noted throughout the surface.Although the sample was returned for evaluation, one electronic photo was provided for review.The investigation is confirmed for the reported fracture and deformation issues, as the 7.0fr peel-apart sheath was noted to be partially peeled.Bunching and bends were noted throughout the sheath shaft.The vessel dilator was noted to be bent with a deformed distal tip.However, the investigation is inconclusive for the reported failure to advance issue, as the exact circumstances at the time of the reported event cannot be verified, and the reported event could not be reproduced in the lab.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: 01/2026).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.H3 other text : see h10.

• Brand Name: M.R.I. LOW-PROFILE IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 7F
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15071854
• Report Number: 3006260740-2022-02837
• Device Sequence Number: 12134853
• Product Code: LJT
• UDI-Device Identifier: 00801741025839
• UDI-Public: (01)00801741025839
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K924250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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: 0603870
• Device Catalogue Number: 0603870
• Device Lot Number: REFS1070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 09/29/2022
• 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