MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MRI HARD B ATT GROSH 8 P; IMPLANTABLE PORT

Model Number	0604520
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the device is pending to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard 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 bard.
Event or Problem Description
It was reported that approximately eleven months after placement of the device; the device was removed allegedly due to a fracture in the catheter.There was no reported patient injury.
Additional Manufacturer Narrative
After further event details provided by the complainant the event description was corrected and the associated fields were updated.There was change to reportability and the file was updated.There were no changes to the investigation summary listed below.No medical records or no medical images have been made available to the manufacturer.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.
Event or Problem Description
It was reported that approximately eleven months after placement of the device; the device allegedly broke and migrated to the pulmonary artery.It was further reported that the catheter was removed.
Additional Manufacturer Narrative
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.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: one mri hard base port with 8f groshong catheter was returned for evaluation.The catheter was returned in two segments, with the proximal segment under the catheter lock on the port stem.A complete circumferential beak of the catheter was noted under the catheter lock between the 17cm and depth markers.The distal end of the catheter break was noted as having some of the catheter material cut out longitudinally at the site of the break.Under magnification, it was noted that both edges of the catheter break were jagged with a smooth surface noted to the proximal end of the break.Buckling was present on the distal end of the break.Based on the findings, the investigation is confirmed for the reported catheter break, specifically a catheter break at the port stem.During functional evaluation, it was noted that the sample was not patent to infusion and aspiration due to blood and residue.Therefore, it's possible that an occlusion contributed to the catheter break.However, the definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the reported event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiration date: 04/2018).
Event or Problem Description
It was reported that approximately eleven months after placement of the device; the device allegedly broke and migrated to the pulmonary artery.It was further reported that the catheter was removed.

• Brand Name: MRI HARD B ATT GROSH 8 P
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7772483
• Report Number: 3006260740-2018-02041
• Device Sequence Number: 1986906
• Product Code: LJT
• UDI-Device Identifier: 00801741025853
• UDI-Public: (01)00801741025853
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K873213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2018

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: 0604520
• Device Catalogue Number: 0604520
• Device Lot Number: REXC1260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 09/05/2018; 11/20/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 09/06/2018; 12/17/2018
• 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
• Patient Age: 79 YR