MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG CATHETER,CANNULA AND TUBING,VASCULAR,CARDIOPUL; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number PIK 150

Device Problem Difficult to Remove (1528)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the hospital: "this incident led to patient death, guidewire coiling after dilating the artery using insertion kit pik 150cm and inserting the cannula, we found difficulty in removing the wire, we used 2 insertio kits and 2 different sites (rfa and lfa) 2 different experts surgeons were involved, due to inability of removal of guidewires." ref.: #(b)(4).

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).Investigation is referred to (b)(4).Only 2 guidewires were returned.With a guide wire, it can be seen that the spring in several places was pulled apart until the middle stabilizing wire of the guidewire broke.The other guidewire has 2 small corroded areas at the beginning of the wire.No further abnormalities noted.The returned guidewires can not be tested in this condition.With a guidewire, it can be seen that the wire spiral was pulled apart in several places until the middle stabilizing wire of the guidewire broke.The other guidewire has 2 small corroded areas at the beginning of the wire.Damaged wires can be confirmed by the laboratory.Sap trend search was performed (material (b)(4), failure code 1008 component) which came to following results: 1 additional complaint was recorded which appears reported issues are the same since the last 12 months.Similar product group shows 3 more additional complaints but 2 reported issues are caused by user error according to investigation.Based on the sales figures of the last 12 months following occurrence rate has been calculated: 0,009%, which is below 1%.Due to this information no systemic issue could be determined.The available information has been shared internally with getinge theraphy application manager.According to clinical director the product investigation does not support a conclusion and we need more information.When further information is available the complaint will be reopened appropriate actions will be performed if necessary.

Event Description

(b)(4).

• Brand Name: CATHETER,CANNULA AND TUBING,VASCULAR,CARDIOPUL
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 7252115
• MDR Text Key: 99364755
• Report Number: 8010762-2018-00046
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K131666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PIK 150
• Device Catalogue Number: 701047385
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2018
• 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
• Patient Outcome(s): Death