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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

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DATASCOPE CORP. - FAIRFIELD LINEAR 7.5 FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number 0684-00-0480-01
Device Problem Break (1069)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
It was reported that during the intra-aortic balloon (iab) insertion process, the dilator and wire were being removed when the dilator hub sheared at the site of the sheath diaphragm, leaving a fragment of the dilator in the patient.Attempts to removed the dilator were made but unsuccessful.The patient required emergent surgical intervention to remove the retained dilator.A new introducer kit was utilized to insert the iab.
 
Manufacturer Narrative
Occupation: supply chain manager additional reporter: (b)(6).The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint record id #: (b)(4).
 
Event Description
It was reported that during the intra-aortic balloon (iab) insertion process, the dilator and wire were being removed when the dilator hub sheared at the site of the sheath diaphragm, leaving a fragment of the dilator in the patient.Attempts to removed the dilator were made but unsuccessful.The patient required emergent surgical intervention to remove the retained dilator.A new introducer kit was utilized to insert the iab.Additional information reported via medwatch report: the patient presented with anterior stemi and had multiple bouts of ventricular arrhythmias prior to arrival.Lad was occluded and an intra-aortic balloon pump was required for hemodynamic stability.Access to place iabp was gained in the left femoral artery using ultrasound guidance and micro-puncture tools.An 0.035" j-tip guidewire was then introduced, and a 7.5 french armored maquet sheath was introduced.As the dilator and wire were being removed, the dilator hub sheared at the site of the sheath diaphragm, leaving fragment of the dilator in the patient.Attempts were made to remove the dilator, but these were unsuccessful.The patient had to go emergently to the operating room to have the retained portion of the dilator removed by an open vascular surgery.
 
Manufacturer Narrative
Updated field(s): date of birth describe event or problem other relevant history initial report sent to fda? report source other source - please specify complaint record id # (b)(4).
 
Event Description
N/a.
 
Manufacturer Narrative
The introducer dilator was returned with dried blood on the component.The hub of the dilator was found broken off from the dilator tubing.The returned dilator was measured and found to be within specification.No other visual defects were identified.The root cause of the issue at this time is impossible to define.A capa has been initiated to investigate this issue further and identify a root cause.Reference complaint#: (b)(4).
 
Manufacturer Narrative
Reference complaint#: (b)(4).
 
Event Description
It was reported that during the intra-aortic balloon (iab) insertion process, the dilator and wire were being removed when the dilator hub sheared at the site of the sheath diaphragm, leaving a fragment of the dilator in the patient.Attempts to removed the dilator were made but unsuccessful.The patient required emergent surgical intervention to remove the retained dilator.A new introducer kit was utilized to insert the iab.Additional information reported via medwatch report: the patient presented with anterior stemi and had multiple bouts of ventricular arrhythmias prior to arrival.Lad was occluded and an intra-aortic balloon pump was required for hemodynamic stability.Access to place iabp was gained in the left femoral artery using ultrasound guidance and micro-puncture tools.An 0.035" j-tip guidewire was then introduced, and a 7.5 french armored maquet sheath was introduced.As the dilator and wire were being removed, the dilator hub sheared at the site of the sheath diaphragm, leaving fragment of the dilator in the patient.Attempts were made to remove the dilator, but these were unsuccessful.The patient had to go emergently to the operating room to have the retained portion of the dilator removed by an open vascular surgery.Additional information received 22apr2024: this is a 66 y.O.Woman who was just recently in cardiology cath lab for balloon pump placement in the setting of a stemi.Per report, during sheath placement, the dilator broke and embolized into the profunda femoris artery.On review of her cath lab imaging, it is unclear where this dilator piece is, as it appears to be radiolucent.She has a palpable dp pulse on examination, however, i felt that it was imprudent to leave an intraarterial foreign body given that it would ultimately result in thrombosis and acute limb ischemia.Therefore, i requested transfer emergently to the hybrid room for exploration.This is a level one case.The patient was brought to the operating room and placed in the supine position on the operating room table.She had already been intubated and hemodynamically unstable on pressors given her recent cardiac event.Anesthesia team was kind enough to place a central and arterial line so that she was not getting epinephrine through a peripheral iv.After this, the patient's abdomen, bilateral groins, and left leg were prepped and draped in the usual sterile fashion.A routine timeout was performed which confirmed the patient, procedure, risk of fire, allergies and confirmed administration of preoperative antibiotics.A longitudinal incision was made in the groin, approximately 1/3 cephalad and 2/3 caudal to the inguinal ligament.We dissected down through the subcutaneous tissue and meticulously ligated each of the lymphatics identified.We identified the inguinal ligament as our proximal landmark.The femoral sheath was incised sharply and we identified the common femoral artery.We removed the previously placed 6 fr sheath placed by the prior interventionalist, and primarily repaired the arteriotomy.The dissection was carried caudal from here, identifying each of the circumflex branches, the superficial femoral artery, and the deep femoral artery.All vessels were circumferentially isolated with vessel loops.We did not palpate any foreign body within the common femoral, superficial femoral, or profunda femoris arteries that would resemble a vascular dilator.Given that our team was told that the tip of the dilator had been lodged in the profunda femoris artery, we were confused and elected to perform an arteriogram.We accessed the common femoral artery with a micropuncture kit and upsized to a 5 fr sheath.We advanced an omniflush catheter over a glide advantage wire into the infrarenal aorta and performed a distal aortogram.We ran this down the left lower extremity as well.We did not appreciate any foreign body within the left lower extremity vasculature.Upon closer inspection, it appeared as if the dilator was in the distal aorta with the tip lodged deep within the internal iliac artery.At this point, we asked interventional radiology to opine on whether there were any options for endovascular removal.Their team was kind enough to review the images and reported that this would be difficult, if not impossible, given that it would need to cross the aortic arch and that there was an active infrarenal balloon pump.We did not want to perform a laparotomy if there was an alternative, given that the patient was on multiple pressor agents and on a ticagrelor drip.Unfortunately, we ultimately elected to perform a laparotomy to remove this dilator given that it would be dangerous to leave this within the patient's distal aorta.We performed a midline laparotomy in the standard fashion.It should be noted that the patient had approximately 15 cm of subcutaneous fat superficial to her fascia which made her laparotomy more difficult than normal.We were able to enter the abdomen in the midline and she was noted to have significant adhesions from her greater omentum to the abdominal wall which we took down with electrocautery.We inspected the small bowel and found no inadvertent injury.At this point, we placed a bookwalter retractor.We mobilized the sigmoid colon and distal rectum off of the left abdominal wall at the retroperitoneal attachments.Given the patient's obesity and the deep pelvis, we had extreme difficulty identifying and exposing the iliac arteries.This warrants a modifier 22.We were finally able to identify the left external iliac artery.From here, we identified the ureter and protected this throughout the case.The left internal iliac artery was exposed with great difficulty but finally we were able to obtain circumferential control around this artery.The tip of the dilator was easily palpated within the arterial lumen.Given the depth of this artery, i did not think that arteriotomy and surgical repair was physically possible.Therefore i made the decision to ligate this artery.The artery was ligated distally, and we placed vessel loops proximally in a potts fashion.An arteriotomy was made and the dilator was easily removed.This will be sent to cardiology for device inspection and quality assurance.After this was removed.The proximal internal iliac artery was ligated with 0-silk suture and large clips.Hemostasis was achieved and the bowel was allowed to fall back into its natural position.The abdomen was irrigated with copious saline.Again, we ran the small and large bowel and did not find any evidence of injury from our retraction or lysis of adhesions.The greater omentum was allowed to cover the entire celiotomy wound.The abdomen was closed with two 0-looped maxon sutures for the fascial layer.All wounds were irrigated with betadine and rinsed with saline, given the contaminated nature of the case.The abdomen closed with staples.The groin was closed in layers with 2-0 vicryl, 3-0 vicryl, and staples for the skin layer.There were no immediate complications.At the end of the case, all needle, instrument and sponge counts were correct.The patient was remained critically ill on pressor and balloon pump support, and was transported to the icu in critical condition.
 
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Brand Name
LINEAR 7.5 FR. 40CC IAB
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer (Section G)
DATASCOPE CORP. - FAIRFIELD
15 law drive
fairfield NJ
Manufacturer Contact
brian schaeffer
15 law drive
fairfield, NJ 
MDR Report Key16707628
MDR Text Key312959162
Report Number2248146-2023-00246
Device Sequence Number1
Product Code DSP
UDI-Device Identifier10607567106564
UDI-Public10607567106564
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041281
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 04/23/2024
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 Model Number0684-00-0480-01
Device Catalogue Number0684-00-0475
Device Lot Number3000258497
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2023
Initial Date Manufacturer Received 03/20/2023
Initial Date FDA Received04/10/2023
Supplement Dates Manufacturer Received04/12/2023
06/08/2023
04/22/2024
Supplement Dates FDA Received05/01/2023
06/08/2023
04/24/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2022
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
UNKNOWN.
Patient Outcome(s) Required Intervention;
Patient Age66 YR
Patient SexFemale
Patient Weight95 KG
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