MAUDE Adverse Event Report: BARD ACCESS SYSTEMS M.R.I. LOW-PROFILE IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 6.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 0603880C

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Deformation Due to Compressive Stress (2889)

Patient Problem Injury (2348)

Event Date 08/11/2020

Event Type  Injury  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products that are cleared in the us.The pro code and 510k number for the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products is identified in common device name, pro code and pma/510(k).As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.Expiry date (01/2022).

Event Description

It was reported that six months post port placement procedure, the catheter allegedly broke.It was further reported that during an attempt to retrieve, the catheter migrated to the atrium.Reportedly the catheter was removed with medical intervention.The patient status was stable.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products that are cleared in the us.The pro code and 510k number for the m.R.I.Low-profile implantable port, hickman single-lumen, 6.6f products is identified in d2 and g5.H10: manufacturing review:the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary:one mri low-profile port, one cath-lock and one catheter was returned for evaluation.Gross visual, microscopic visual, functional and dimensional evaluations were performed.The investigation is confirmed for catheter fracture and deformation issue as a circumferential split was noted to the catheter approximately 4mm from the port body.The port body with attached catheter segment was patent to infusion with a leak noted at the circumferential split.Aspiration was attempted but was unsuccessful; no air was aspirated into the syringe.The investigation is inconclusive for catheter migration as the clinical conditions cannot be replicated.Complaint due to ¿port catheter fractured¿ was confirmed but the exact cause is unknown.According with the photo evaluation performed at reynosa facility and gross visual, microscopic visual, measurements taken, and functional testing performed at bdpi lab the following was concluded: the white catheter was loaded onto the port stem; however, the cath-lock was found to be loosened.A closer view of the catheter showed an uneven circumferential split.Several puncture accesses were noted on the port septum.Tool marks appeared to be present on the surface of the cath-lock.A small indentation was also visible at the proximal end.The inner diameter of the cath-lock was found to be above of specification limits.Blood residue was observed through the sample.Due the fact of the inner diameter of the cath-lock was found above of specification limits during evaluation, an incident report was issued to notify our supplier about this issue.Therefore, the investigation is confirmed for the port stem outer diameter and cath-lock inner diameter measurements being out of tolerance.Therefore, as the definitive root cause of this damage could not be determined the cause of this condition remains unknown.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: 01/2022),g4,h6(result :2292) h11: b3,h6(method, result and conclusion) 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.

Event Description

It was reported that six months post port placement procedure, the catheter allegedly broke.It was further reported that during an attempt to retrieve, the catheter migrated to the atrium.Reportedly the catheter was removed with medical intervention.The patient status was stable.

• Brand Name: M.R.I. LOW-PROFILE IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 6.6F
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10498989
• MDR Text Key: 205902673
• Report Number: 3006260740-2020-03184
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741111167
• UDI-Public: (01)00801741111167
• Combination Product (y/n): N
• PMA/PMN Number: K924250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0603880C
• Device Lot Number: REDP3370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 65