MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG 12210#VAK, GUIDEWIRE 210CM; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 701063540

Device Problem Sticking (1597)

Patient Problem Injury (2348)

Event Date 04/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device and its lot number were requested for evaluation but are not available anymore.Further information is requested by the manufacturer.Based on the information a clinical evaluation will be created.A supplement medwatch will be submitted if additional information becomes available.

Event Description

It was reported that during patient treatment when attempting to dilate with the "12210#vak, guidewire 210cm" in question the 30 fr dialator seemed to get stuck.This resulted in a vessel injury.(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary (b)(4) requested the product for manufacturer's laboratory investigation but the product was not available for investigation.Based on the received information no clinical assessment could be performed as no further information was available and product was not available for investigation.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.Therefore this complaint is closed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further investigation initiations will be completed at this time.

Event Description

(b)(4).

• Brand Name: 12210#VAK, GUIDEWIRE 210CM
• 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: 5738447
• MDR Text Key: 47834283
• Report Number: 8010762-2016-00398
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K081820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701063540
• Device Catalogue Number: 12210#VAK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/19/2016
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2016
• Initial Date Manufacturer Received: 04/19/2016
• Initial Date FDA Received: 06/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/24/2016
• 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): Other