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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT ISP M.R.I. IMPLANTABLE PORT WITH ATTACHABLE 8F GROSHONG SINGLE-LUMEN; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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BARD ACCESS SYSTEMS POWERPORT ISP M.R.I. IMPLANTABLE PORT WITH ATTACHABLE 8F GROSHONG SINGLE-LUMEN; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Model Number 9808560
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Perforation (2001)
Event Date 03/01/2018
Event Type  Injury  
Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records could not be performed.The device is pending return 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.Device not returned at this time.
 
Event Description
It was reported that during the placement procedure, the stylet was not removed prior to cutting the catheter and was implanted into the patient.The patient went to the hospital stating that the wire had pierced the wall of the right atrium, the chest wall and the left breast, and exposed to the skin.The device was removed.
 
Event Description
It was reported that during port device implant, the physician allegedly did not remove the stylet prior to cutting the catheter and then proceeded to implant.It was further reported that the patient presented to the hospital after noticing that the device had exposed through the skin.The patient was hospitalized and a scan was performed that demonstrated that the wire had pierced the wall of the right atrium, the chest wall, and the left breast.Reportedly, the stylet was removed, however the device remained in the patient.There was no report of patient status post removal procedure.
 
Manufacturer Narrative
It was identified that the fda rn number was incorrect and the correct fda rn number is 3006260740.This number will not be changed on the emdr so that this report will remain connected and identify that the event was reported to the fda in a timely manner.Manufacturing review: a complete manufacturing review could not be performed, as the lot number is unknown.Investigation summary: one stylet was returned for evaluation.The stylet was returned in two segments, one larger and one smaller.Both segments had a matching fracture surface, consistent with reports that it was cut.The smaller segment had two distinct bends.Based on the findings, the investigation is confirmed for the reported cut stylet.Per the evaluation results, the stylet was received in two segments, both possessing fracture surfaces consistent with a break, and the stylet possessed bends consistent with being implanted.This is consistent with the reported event details, which state that the stylet was not removed from the catheter prior to cutting it.This is warned against in the warnings section of the powerport ifu: "for implantable ports with groshong catheters, do not cut stylet.Withdraw stiffening stylet from catheter prior to cutting." as it was reported that the physician forgot to remove the stylet prior to placement, the root cause has been determined to be use-related.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.
 
Event Description
It was reported that during port device implant, the physician allegedly did not remove the stylet prior to cutting the catheter and then proceeded to implant.It was further reported that the patient presented to the hospital after noticing that the device had exposed through the skin.The patient was hospitalized and a scan was performed that demonstrated that the wire had pierced the wall of the right atrium, the chest wall, and the left breast.Reportedly, the stylet was removed, however the device remained in the patient.There was no report of patient status post removal procedure.
 
Manufacturer Narrative
It was identified that the fda rn number was incorrect and the correct fda rn number is 3006260740.This number will not be changed on the emdr so that this report will remain connected and identify that the event was reported to the fda in a timely manner.Additionally, the below investigation summary did not change from the previously reported supplemental emdr.Manufacturing review: a complete manufacturing review could not be performed, as the lot number is unknown.Investigation summary: one stylet was returned for evaluation.The stylet was returned in two segments, one larger and one smaller.Both segments had a matching fracture surface, consistent with reports that it was cut.The smaller segment had two distinct bends.Based on the findings, the investigation is confirmed for the reported cut stylet.Per the evaluation results, the stylet was received in two segments, both possessing fracture surfaces consistent with a break, and the stylet possessed bends consistent with being implanted.This is consistent with the reported event details, which state that the stylet was not removed from the catheter prior to cutting it.This is warned against in the warnings section of the powerport ifu: "for implantable ports with groshong catheters, do not cut stylet.Withdraw stiffening stylet from catheter prior to cutting." as it was reported that the physician forgot to remove the stylet prior to placement, the root cause has been determined to be use-related.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.
 
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Brand Name
POWERPORT ISP M.R.I. IMPLANTABLE PORT WITH ATTACHABLE 8F GROSHONG SINGLE-LUMEN
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 Key7500820
MDR Text Key107820796
Report Number2020394-2018-00632
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741027512
UDI-Public(01)00801741027512
Combination Product (y/n)N
PMA/PMN Number
K063377
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 01/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9808560
Device Catalogue Number9808560
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2018
Date Manufacturer Received01/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age62 YR
Patient Weight58
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