MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CANNULA & CATHETER; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number BE-PAS 1915 -J#BE-HLS CANNULA 19F AS

Device Problem Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2023

Event Type  malfunction  

Event Description

"when the product (be-pas 1915) was introduced to the patient, an event occurred in which it could not be inserted.Although the details of the cause are unknown, the patient was an elderly woman who was able to reduce the size and reissue 15fr, and was able to successfully insert it and was able to use it clinically.There was no health damage to the patient due to this event." complaint #: (b)(4).

Manufacturer Narrative

The product was requested for investigation.A follow-up medwatch will be submitted when further information becomes available.

Event Description

Complaint #: (b)(4).

Manufacturer Narrative

It was reported that when the product (be-pas 1915 hls cannula) was introduced to the patient, an event occurred in which it could not be inserted.Although the details of the cause are unknown, the patient was an elderly woman who was able to reduce the size and reissue 15fr, and was able to successfully insert it and was able to use it clinically.There was no health damage to the patient due to this event.No harm to any person was reported.The product was investigated in getinge laboratory.During opening the delivered package a foreign body was found on the tip of the introducer.However, this was not reported by the customer initially in this complaint.The foreign material could be caused by handling after unsuccesful insertion until arriving in laboratory.The hls cannula and introducer were found bent.The tip of the introducer was also bent.The original packaging was not available which includes a protection tube to prevent any kind of tip bending.The bending of the introducer tip resulted from the improvised packaging of the complaint cannula (to the contamination lab).The diameter measurement of the introducer and the cannula body showed no deviations.The cannula body is free from visual defects and fully functional, there is no technical issue identified for this complaint.The customer had issue with inserting the cannula in the patient¿s vessel and reducing the french size (outer diameter) of the cannula led to succesfully insertion.The production history record (dhr) of the affected be-pas 1915 -j with lot # 3000280411 was reviewed.According to the dhr results, the product be-pas 1915 -j passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.The most probable root cause is a user error, hence from a technical standpoint the cannula is fully functional.It is most likely the wrong cannula size had been chosen concerning the health status of the patient, since as it is mentioned in the description, with a smaller size cannula (15fr) the insertion was performed without issues.The root cause could not be confirmed.The failure could not be confirmed.Warnings are placed in instruction for use of hls cannulae set, g-139, v05, page 10 under "safety instructions for cannulae": - carefully select the appropriate size of cannula for the particular patient.Determine the vessel diameter, if necessary.- before cannulation, the physician must ensure that the vessel diameter is large enough to allow adequate perfusion of the extremities.The occurrence rate was calculated for the reported failure and product and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

• Brand Name: CANNULA & CATHETER
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 17687975
• MDR Text Key: 322712403
• Report Number: 8010762-2023-00446
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

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
• Device Operator: Health Professional
• Device Model Number: BE-PAS 1915 -J#BE-HLS CANNULA 19F AS
• Device Catalogue Number: 701067487
• Device Lot Number: 3000280411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2023
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 11/10/2023
• Supplement Dates FDA Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/16/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Female