MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR PERCUTANEOUS SHEATH INTRODUCER SET; CATHETER, PERCUTANEOUS

Model Number I305BF9

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/30/2016

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However the complaint could not be confirmed without the completion of the product evaluation.A supplemental report will be forthcoming with the evaluation results.Lot number was not provided, therefore review of the manufacturing records could not be completed.

Event Description

It was reported that the side arm of the introflex introducer fell off when patient returned from operating theatre.Pressure was immediately applied to site by the clinician and the catheter was removed from the patient.There was no medication loss due to this event nor allegation of patient injury.The introflex introducer is available for evaluation.

Manufacturer Narrative

Although the device was not received for examination an image evaluation was conducted off of a photo.Examination of the photos shows an hemostasis type introflex introducer where the side arm extension tube has detached from the valve housing.It is impossible to determine from the photos if the side arm tube was bonded correctly prior to the detachment.The tube does not appear to be broken.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.

Manufacturer Narrative

It was indicated from the customer that device has been discarded and would not be returned for examination.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.

Manufacturer Narrative

Correction made as device was not returned.Examination was based on a photo.

• Brand Name: PERCUTANEOUS SHEATH INTRODUCER SET
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: brian hurd-servin ; 1 edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 5628277
• MDR Text Key: 44911964
• Report Number: 2015691-2016-01458
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K831729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/12/2016

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: I305BF9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2016
• Initial Date FDA Received: 05/03/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/06/2016; 07/11/2016; 07/11/2016
• 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