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

Model Number 12210#VAK, GUIDEWIR

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Tissue Damage (2104)

Event Date 03/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).Based on the received information no investigation could be performed as no further information was available and product was not available for investigation.Packaging and product was scrapped by the customer.Furthermore the device history record of the product in question could not be reviewed as the lot # was not available.A review for similar complaints for the specific product has been performed and no similar incident with a failure confirmed was found.Based on this a confirmation of the failure is not possible.Mcp opened a scar process in order to investigate the observation and define actions steps ((b)(4)).All further actions will be performed out of this internal process.Thus the record will be closed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

A critically ill patient who was on ecmo was brought to the or for conversion from va ecmo to vav ecmo.This patient had limited vascular access.The only kit stocked at vgh has a 210cm wire.The kit was opended and the wire was inserted in the patients femoral vein.After the wire was inserted it was noted that the wire was not 210 cm it was much shorter.Every effort was made to reinsert a longer wire (we opened a new inerstion kit) however it was not possible.A vascular surgeon has to be called in to repair the vein and a cut down needed to be preformed to place a cannula.Hospital unable to provide more product information, they assume/ and claim it was vascular access kit vak 12210, but this cannot be confirmed as no packaging or product available as scrapped.(b)(4).

• Brand Name: CATHETER GUIDE WIRE
• 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: 7421760
• MDR Text Key: 105400743
• Report Number: 8010762-2018-00130
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K081820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/11/2018

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: 12210#VAK, GUIDEWIR
• Device Catalogue Number: 701063540
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2018
• Initial Date FDA Received: 04/11/2018
• 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