MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG JOSTRA SUCTION DEVICE; FLEXIBLE SUCTION DEVICE

Catalog Number 70103.2370

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 11/18/2014

Event Type  Injury  

Event Description

It was reported that during surgery, the suction connector came off the product and the tip of the ribbed suction nozzle also came off.The tip of the ribbed suction nozzle dropped into the pericardium, but was removed.The device was exchanged for another, which had the suction connector also fall off.The physician stopped using the device.No reported patient effect.(b)(4).This event is related to medwatch report # 8010762-2014-01363 for the second device.

Manufacturer Narrative

Maquet cardiopulmonary ag has not received the device back for evaluation.A supplemental medwatch will be submitted when additional information becomes available.

• Brand Name: JOSTRA SUCTION DEVICE
• Type of Device: FLEXIBLE SUCTION DEVICE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strabe 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4360214
• MDR Text Key: 5234458
• Report Number: 8010762-2014-01338
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K020983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/20/2014

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 Expiration Date: 05/01/2016
• Device Catalogue Number: 70103.2370
• Device Lot Number: 92109087
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2014
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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): Required Intervention