MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD NON-POWER PORT WITH 8 F ATTACHABLE GROSHONG VALVED CATHETER; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0602810
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was not provided, therefore, the device history records were not reviewed.The return of the device is pending.The investigation is currently underway.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 or Problem Description
It was reported that two years and two months post port placement, a scan allegedly demonstrated the port catheter ruptured and migrated to the artery level of the left lung.It was further reported that the additional intervention was used to complete removal of the migrated segment.Reportedly, the device was removed.The current status of the patient is unknown.
Event or Problem Description
It was reported that two years and two months post port placement, a scan allegedly demonstrated the port catheter ruptured and migrated to the artery level of the left lung.It was further reported that the additional intervention was used to complete removal of the migrated segment.Reportedly, the device was removed.The current status of the patient is unknown.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged broken/migrated catheter as no objective evidence has been provided to confirm any alleged deficiency with the catheter.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Possible contributing factors include flexural fatigue, pinch off, and catheter occlusion; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).Labeling review: a review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.

• Brand Name: BARD NON-POWER PORT WITH 8 F ATTACHABLE GROSHONG VALVED CATHETER
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8276398
• Report Number: 3006260740-2019-00079
• Device Sequence Number: 1952799
• Product Code: LJT
• UDI-Device Identifier: 00801741025693
• UDI-Public: (01)00801741025693
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2019

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: 0602810
• Device Catalogue Number: 0602810
• Device Lot Number: REZG2230
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/28/2018
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 03/29/2019
• 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