MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L 28GA (1.2F) X 25CM 1 LUMEN)

Model Number 384516

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528); Difficult to Advance (2920); Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/01/2022

Event Type  malfunction  

Manufacturer Narrative

The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.

Event Description

We had a picc line fail in the nicu.The items that failed are the introducer, item 38770 and the picc catheter, item 35769 which is a kit.The introducer and picc kit are both made by kentec medical inc.I have part of what failed, the lot # and patient info.What ca has kentec medical so i can drop off the broken device? (b)(6) has the photos of the x-ray if more info is needed by kentec.(b)(4).2100 picc placement attempt occurred in l leg by (b)(6) rn w/ supervision by (b)(6) rn.With first stick, excellent blood return and catheter was introduced into saphenous vein w/ both of us involved in the process.Catheter initially advanced, then hit resistance.Upon attempt to retract catheter in order to attempt threading again, catheter became completely stuck and would not move inward or outward at all.Complete resistance both ways, as if the catheter was physically stuck in the introducer.Upon attempt to dislodge catheter so we could remove introducer and catheter completely from the vessel, we found the catheter to be damaged and torn at the tip after removal from vessel, with approximately 5cm missing and instead just the guidewire was exposed.Unable to tell if the catheter was lodged into the introducer itself because it was a splitable needle and there are shards of pieces after splitting said needle.Inspected closely by us both.Site inspected closely and didn't appear to be inflamed, edematous, or especially concerning.Md team notified, all agreed to closely monitor baby's clinical status, as well as visualize extremity at least q1h.Successful picc (1st attempt) put in r leg shortly after that (@ 2140).Baby clinically stable throughout shift.Serial x-rays performed around 0320 d/t concern for bowel loops on 2140 x-ray.Upon closer visualization of these 0320 x-rays, nicu team and radiology team came to the conclusion that we can see two catheters, one being centrally located at ivc (from r leg picc), and the other being a short catheter "floating" in the area of the atrium.(b)(6) pa and (b)(6) md notified immediately of findings.(b)(6) md called and updated.Poc called and updated.Emergent transfer to children's initiated @ 0500 for ir intervention and close cardiac observation.Stable piv placed in l forearm in case picc is d/c'ed d/t its location in the saphenous/ivc.Damaged catheter placed in (b)(6) box.Catheter lot #11395246 - 1.2 fr l-cath (bd).Fyi: catheter was cut @ 23cm.18cm remained after damage.Photos of x-rays sent to (b)(6) via email but can also be visualized on epic.

Event Description

We had a picc line fail in the nicu.The items that failed are the introducer, item 38770 and the picc catheter, item 35769 which is a kit.The introducer and picc kit are both made by kentec medical inc.I have part of what failed, the lot # and patient info.What ca has kentec medical so i can drop off the broken device? (b)(6) has the photos of the x-ray if more info is needed by kentec.(b)(4).2100 picc placement attempt occurred in l leg by (b)(6) rn w/ supervision by (b)(6) rn.With first stick, excellent blood return and catheter was introduced into saphenous vein w/ both of us involved in the process.Catheter initially advanced, then hit resistance.Upon attempt to retract catheter in order to attempt threading again, catheter became completely stuck and would not move inward or outward at all - complete resistance both ways, as if the catheter was physically stuck in the introducer.Upon attempt to dislodge catheter so we could remove introducer and catheter completely from the vessel, we found the catheter to be damaged and torn at the tip after removal from vessel, with approximately 5cm missing and instead just the guidewire was exposed.Unable to tell if the catheter was lodged into the introducer itself because it was a splitable needle and there are shards of pieces after splitting said needle.Inspected closely by us both.Site inspected closely and didn't appear to be inflamed, edematous, or especially concerning.Md team notified, all agreed to closely monitor baby's clinical status, as well as visualize extremity at least q1h.Successful picc (1st attempt) put in r leg shortly after that (@ 2140).Baby clinically stable throughout shift.Serial x-rays performed around 0320 d/t concern for bowel loops on 2140 x-ray.Upon closer visualization of these 0320 x-rays, nicu team and radiology team came to the conclusion that we can see two catheters, one being centrally located at ivc (from r leg picc), and the other being a short catheter "floating" in the area of the atrium.(b)(6) md notified immediately of findings.(b)(6) md called and updated.Poc called and updated.Emergent transfer to children's initiated @ 0500 for ir intervention and close cardiac observation.Stable piv placed in l forearm in case picc is d/c'ed d/t its location in the saphenous/ivc.Damaged catheter placed in (b)(6) box.Catheter lot #11395246 - 1.2 fr l-cath (bd).Fyi: catheter was cut @ 23cm.18cm remained after damage.Photos of x-rays sent to (b)(6) via email but can also be visualized on epic.

Manufacturer Narrative

A review of the dhr and inspection records was conducted, and no similar concerns were found.A section of an opened catheter was returned for review along with a stylet that was severely kinked.The returned section of the catheter was measured and found to be approximately 18.5 cm.Long which was consistent with the report from the customer.The customer stated that the catheter was cut at 23 cm which signifies that approximately 4.5 cm of the catheter tubing was missing.Therefore, this complaint was confirmed for breakage.The most probable cause for the catheter breakage was most likely due to an event within the user environment.The customer stated that resistance was experienced when trying to retract the catheter.Possibly the resistance that was experienced was due to the vessel contracting.The ifu cautions, "if resistance is felt, stop removal.Apply warm compress and wait 20-30 minutes." this will give the vessel time to relax.Since the reported issue was most likely related to an event within the user environment and not a manufacturing error, no corrective action will be taken.

Manufacturer Narrative

The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.

Event Description

We had a picc line fail in the nicu.The items that failed are the introducer, item 38770 and the picc catheter, item 35769 which is a kit.The introducer and picc kit are both made by kentec medical inc.I have part of what failed, the lot # and patient info.What ca has kentec medical so i can drop off the broken device? alyssa has the photos of the x-ray if more info is needed by kentec.Si-59421 2100 picc placement attempt occurred in l leg by b.Boyajian rn w/ supervision by k.Watkins rn.With first stick, excellent blood return and catheter was introduced into saphenous vein w/ both of us involved in the process.Catheter initially advanced, then hit resistance.Upon attempt to retract catheter in order to attempt threading again, catheter became completely stuck and would not move inward or outward at all - complete resistance both ways, as if the catheter was physically stuck in the introducer.Upon attempt to dislodge catheter so we could remove introducer and catheter completely from the vessel, we found the catheter to be damaged and torn at the tip after removal from vessel, with approximately 5cm missing and instead just the guidewire was exposed.Unable to tell if the catheter was lodged into the introducer itself because it was a splitable needle and there are shards of pieces after splitting said needle.Inspected closely by us both.Site inspected closely and didn't appear to be inflamed, edematous, or especially concerning.Md team notified, all agreed to closely monitor baby's clinical status, as well as visualize extremity at least q1h.Successful picc (1st attempt) put in r leg shortly after that (ay 2140).Baby clinically stable throughout shift.Serial x-rays performed around 0320 d/t concern for bowel loops on 2140 x-ray.Upon closer visualization of these 0320 x-rays, nicu team and radiology team came to the conclusion that we can see two catheters, one being centrally located at ivc (from r leg picc), and the other being a short catheter "floating" in the area of the atrium.(b)(6) pa and (b)(6) md notified immediately of findings.(b)(6) md called and updated.Poc called and updated.Emergent transfer to (b)(6) initiated at 0500 for ir intervention and close cardiac observation.Stable piv placed in l forearm in case picc is d/c'ed d/t its location in the saphenous/ivc.Damaged catheter placed in alyssa knepp's box.Catheter lot #11395246 - 1.2 fr l-cath (bd).Fyi: catheter was cut at 23cm.18cm remained after damage.Photos of x-rays sent to (b)(6) via email but can also be visualized on epic.

• Brand Name: L-CATH PICC S/L 28GA (1.2F) X 25CM 1 LUMEN)
• Type of Device: L-CATH PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 15076043
• MDR Text Key: 296371370
• Report Number: 0001625425-2022-01044
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00886333209910
• UDI-Public: 00886333209910
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 384516
• Device Catalogue Number: 384516
• Device Lot Number: 11395426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other