MAUDE Adverse Event Report: PULSION MEDICAL SYSTEMS SE PICCO CATHETER; PROBE, THERMODILUTION

Model Number PV2015L20-A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ischemia (1942); Vascular Dissection (3160)

Event Date 02/25/2021

Event Type  Injury  

Manufacturer Narrative

Further information has been requested and investigation is still ongoing.A dhr review could not yet be performed as no batch number could be identified by the customer.No similar serious incidents have been reported within the last 12 months worldwide considering more than (b)(4) units sold (all models of picco catheter).A supplemental emdr will be sent when the investigation is completed.Device discarded by the hospital.

Event Description

The customer reported the following: this is an acute ischemia of the lower limb on femoral arterial catheterization after insertion of a picco-type catheter which led to the patient's right transfemoral supranimal amputation.A dissection of the right external iliac artery was observed resulting in significant luminal narrowing, followed by complete occlusion of the entire arterial axis of the right lower limb starting at the level of the common femoral artery.The incident occurred on (b)(6) 2021 and led to the amputation of the patient, (b)(6), with no known medical history but no medical follow-up, and admitted for sars-cov2 infection.There was no known contraindication to catheter placement (no arterial atheroma of the lower limbs, no bypass, or bi-femoral aorto prosthetic material).It should be noted a chronic alcohol-smoking in the patient.Further questions have been send to the customer in order to identify any relation between the artery dissection/amputation and the used picco catheter.Manufacturer reference: #: (b)(4).

Manufacturer Narrative

Dissection of the right external iliac artery followed by complete occlusion of the entire arterial axis of the right lower limb detected after 8 hours use of picco catheter.Ischemia exceeded.No revascularization possible.Amputation in the orthopedic unit on (b)(6) 2021.On the basis of the provided information it cannot be fully clarified if the picco catheter contributed to the occurrence of the artery dissection followed by an ischemia and amputation.The insertion of any foreign body into the human body presents a risk to the patient.In general, product, patient, or user related factors can support the occurrence of adverse events during insertion or use of any kind of arterial catheter.It lays in the discretion of the treating physician to weigh this risk against the benefits of the technology for the specific patient.This is stated in the product ifu: "contraindications: picco catheters are not intended for any use other than which is indicated.The catheter may not be used in patients where the placement of an indwelling arterial catheter is contraindicated e.G.In the case of arterial prostheses, insufficient perfusion or tissue damages around the puncture site as well as severe peripheral vascular diseases.A picco catheter should only be used if the expected results are reasonable in comparison to the risks." the involved catheter was not sent in as it was discarded by the customer.Therefore it is not possible to determine if the used catheter had any malfunction or any deviation from the specification.The lot number has not been provided.All applicable picco catheter lots, which have been sent to the hospital in the time period between 2020 and (b)(6) 2021 have been reviewed.But did not reveal any non conformity or deviation from specification relevant for the reported issue.A sample of a lot retained by the legal manufacturer has been inspected.The inspection did not indicate any deviation or malfunction, which could have contributed or caused the described event.On the basis of the provided information it is not known if an handling error during insertion procedure occurred.However, the customer reported that no problems or complications have been encountered during catheter placement and the insertion has been supported by ultrasound.Additionally, the peripheral perfusion distal to the insertion site was monitored.A positive history of chronic alcohol and nicotine abuse was reported and the patient was suffering from covid-19.Alcohol and nicotine consume are known contributors of vascular disease.The effects of sars-cov-2 on the vascular system are not yet fully understood.These influences, singularly or in combination, may have contributed to vascular degradation and could have promoted arterial dissection.The instructions for use has indications about possible complications as ischemia and vessel wall perforation.Additionally, the ifu indicates how control of a low perfusion should be performed when catheter is placed.Complaint trending (no similar complaints have been received within the last 12 months) does not point to a systematic manufacturing or design issue.The rate of an adverse event (thrombosis, ischemia, artery dissection) in association with a picco catheter is monitored on the market.The frequency of the incidents in association with a picco catheter known to us is far below the published average of complications with arterial catheters.The investigation did not point to malfunctions, failures or changes in the characteristics or the performance or an inadequacy in the labeling or the instructions of the medical device.The most probable root cause is seen in a known complication during arterial cannulation supported by the patient status (chronic alcoholic smoking, covid-19).No early situation, potential seriousness or adverse trend could be detected.The risk analysis of the product remains valid.The complaint investigation has been performed to the most possible extent.Upon the event occurrence the device was involved and used on a patient for advanced hemodynamic monitoring.The issue will be further monitored on the market.As there is no trend for this kind of issue no additional actions will be taken.The complaint will be closed.

Event Description

Manufacturer reference: #(b)(4).

• Brand Name: PICCO CATHETER
• Type of Device: PROBE, THERMODILUTION
• Manufacturer (Section D): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622
• Manufacturer (Section G): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622
• Manufacturer Contact: christina carlsohn ; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622 ; 0894599140
• MDR Report Key: 12615432
• MDR Text Key: 276382153
• Report Number: 3013876692-2021-00050
• Device Sequence Number: 1
• Product Code: KRB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K171620
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 11/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PV2015L20-A
• Device Catalogue Number: 6885049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/27/2021
• Distributor Facility Aware Date: 11/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/27/2021
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 64 YR