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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS X-PORT ISP WITH GROSHONG CATHETER - JAPAN ONLY; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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BARD ACCESS SYSTEMS X-PORT ISP WITH GROSHONG CATHETER - JAPAN ONLY; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Catalog Number 7707540J
Device Problems Break (1069); Fracture (1260); Material Separation (1562)
Patient Problem Embolism (1829)
Event Date 11/28/2019
Event Type  Injury  
Manufacturer Narrative
Photos were provided to the manufacturer.As the lot number for the device was not provided, a review of the device history records has not been performed.The device is not available for return.The investigation is currently underway.
 
Event Description
It was reported that approximately seven months post port placement via right subclavian vein in the right upper chest, positron emission tomography/computed tomography (pet-ct) imaging allegedly demonstrated a catheter break between the 7 and 8 cm markers.Reportedly, the distal catheter segment allegedly migrated into the heart.The port and catheter were removed.The patient was reportedly stable.
 
Event Description
It was reported that approximately seven months post port placement via right subclavian vein in the right upper chest, positron emission tomography/computed tomography (pet-ct) imaging allegedly demonstrated a catheter break between the 7 and 8 cm markers.Reportedly, the distal catheter segment allegedly migrated into the heart.The port and catheter were removed.The patient was reportedly stable.
 
Manufacturer Narrative
H10: manufacturing review: a lot history record review could not be completed as the lot number was not provided.Investigation summary: one x-port isp with groshong catheter in two segments was received and evaluated.The proximal segment was returned attached to the port body.Gross examination of the port segment showed multiple puncture access of the port septum.A complete elliptically shaped circumferential break was noted at approximately 11.6cm from the distal end of the cath-lock.The tactile evaluation showed necking at the crease sites.The sample segments were independently patent to infusion and aspiration and no leaks were observed.3 photos were evaluated.One photo shows one x-port isp with groshong catheter in two segments with the proximal segment attached to the port body.The second photo shows a close up of the x-port isp with groshong catheter in two segments.The third photo shows the two separate segments of catheter with circumferential break ends of the tubing.Photos of the complaint sample supplied by the complainant shows conformation with the sample received.The investigation confirms the catheter break issue.A definitive root cause could not be determined.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.H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the x-port isp with groshong catheter products that are cleared in the us.The 510 k number and pro code for the x-port isp with groshong catheter products are identified in d2 and g5.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.
 
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Brand Name
X-PORT ISP WITH GROSHONG CATHETER - JAPAN ONLY
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 Key9545688
MDR Text Key173569416
Report Number3006260740-2019-04042
Device Sequence Number1
Product Code LJT
UDI-Device Identifier00801741098246
UDI-Public(01)00801741098246
Combination Product (y/n)N
PMA/PMN Number
K050310
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 06/15/2020
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
Device Operator Health Professional
Device Catalogue Number7707540J
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2020
Initial Date Manufacturer Received 12/09/2019
Initial Date FDA Received01/03/2020
Supplement Dates Manufacturer Received06/15/2020
Supplement Dates FDA Received06/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age59 YR
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