MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BE-PVL 2355#BE-HLS CANNULA 23F VL

Model Number 70104.7295

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/18/2015

Event Type  malfunction  

Event Description

It was reported that during patient treatment it was difficult to remove the femoral cannula due to a kink in the cannula and a defect of the wire-reinforcement at 15 cm from the tip.When the surgeon had put the cannula in place there was no difficulty observed.This had no negative effect on the treated patient.(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary (b)(4) has not received and investigated the claimed cannulae yet.The product failure investigation, analysis and resolution for the claimed cannulae described in this report will be provided by maquet cardiopulmonary (b)(4).A supplemental medwatch will be submitted as soon as additional information becomes available.

Manufacturer Narrative

Maquet cardiopulmonary received and investigation the "be-pvl 2355#be-hls cannula 23f vl".After the device in question was cleaned a visual inspection was conducted.This inspection showed that the cannula has two damages.The first one is located 12 cm and the second one is located 16cm from the end of the introducer.Therefore the failure could be confirmed.It was reported that the problem was recognized when the cannula was removed from the patient and no difficulties were experienced while placing the cannula.Therefore it could be concluded that the kinks occurred after the cannula had already been inserted.Based on this information, the most probable root cause is a damage of the product due to excessive external force on the product during patient treatment.This is the first time of occurrence of this kind of damage.Due to this no further investigation, initiations will be completed at this time.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.

• Brand Name: BE-PVL 2355#BE-HLS CANNULA 23F VL
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437
• MDR Report Key: 4653187
• MDR Text Key: 5604677
• Report Number: 8010762-2015-00305
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K102532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/26/2015

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: 70104.7295
• Device Catalogue Number: BE-PVL 2355#BE-HLS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2015
• Initial Date FDA Received: 03/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1