MAUDE Adverse Event Report: PULSION MEDICAL SYSTEMS SE PULSION PULSIOCATH THERMODILUTION CATHETERS; PROBE, THERMODILUTION

Model Number	PV2015L20-A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further information has been requested and investigation is ongoing.A supplemental emdr will be sent when the investigation is completed.Waiting for product return.
Event or Problem Description
It was reported that after ultrasound driven femoral puncture, the end of the guidewire got almost broken.After the dilatation and insertion of the cannula, it was not feasible to pull the guide wire out, only with the cannula.The damage of the guidewire was observed after removal from the patient.No clinical consequences or harm to the patient occurred.Insertion of a new catheter was needed.Manufacturer reference #: (b)(4).
Event or Problem Description
Manufacturer reference #: (b)(4).
Additional Manufacturer Narrative
During investigation of the returned sample the original complaint description could not be confirmed: the guidewire is complete, and neither separated nor uncoiled.The investigation revealed small kinks at the j-tip and more kinks on the straight end of the guidewire and therefore failed to meets its specification.It is considered as unlikely that the guidewire was kinked before use, as the insertion of guidewire could be performed.This is supported by the customer statement that the bent was detected after removal.A review of the dhr could not identify any non conformities or deviations relevant to the reported issue.No further complaints were received to this batch.The picco technology is used for advanced hemodynamic monitoring.Considering the issue description and investigation results it is considered as likely that a handling error by using excessive force is the root cause for the extent of kinks on the straight end side.As the ifu states: "use of excessive force may tear off the guide wire.Therefore, guide wire and catheter are to be removed simultaneously." additionally, the customer reported that the guidewire was retracted with the cannula in place.It is considered as likely that the j-tip of the guidewire was kinked by retracting the guidewire against the cannula.This is classified as user error as the ifu indicates(lab-000156 ver.01): "if resistance is encountered when removing the guide wire, the guide wire could be kinked about tip of catheter within vessel (k).In this case withdraw the catheter by 2 to 3 cm and try again to remove the guide wire.".

• Brand Name: PULSION PULSIOCATH THERMODILUTION CATHETERS
• Common Device Name: PROBE, THERMODILUTION
• Manufacturer (Section D): PULSION MEDICAL SYSTEMS SE; hans-riedl-strasse 17; feldkirchen 85622 ; GM 85622
• MDR Report Key: 9237326
• Report Number: 3003263092-2019-00017
• Device Sequence Number: 13492916
• Product Code: KRB
• UDI-Device Identifier: 04250094500931
• UDI-Public: (01)04250094500931(17)230930(10)660718
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K171620
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: PV2015L20-A
• Device Catalogue Number: PV2015L20-A
• Device Lot Number: 660718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Weight: 68