MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ POLYMER BLEND TRUE SIZE C-TIP CONTROLCATH TD; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number C144F7

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2016

Event Type  malfunction  

Manufacturer Narrative

We received one c144f7 catheter with monoject 3ml limited volume syringe for examination.The reported event of "difficulty to maintain the inflation" was confirmed.There was no damage found to the catheter body during the visual examination.When attempting to inflate the balloon, the balloon would not inflate and no occlusion was felt.Further examination found the inflation lumen to be open at the catheter tip.The inflation lumen at the tip appears to have reopened after manufacturing.The balloon was able to be inflated by placing a finger over the tip of the catheter to block the opening.The distal and proximal lumens were found to be patent and did not leak.A review of the manufacturing records indicated that the product met specifications upon release.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.

Event Description

It was reported that balloon inflation was difficult to maintain prior to use.There was no allegation of patient injury.The swan-ganz controlcath is available for evaluation.

• Brand Name: SWAN-GANZ POLYMER BLEND TRUE SIZE C-TIP CONTROLCATH TD
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 5779887
• MDR Text Key: 49087476
• Report Number: 2015691-2016-02174
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K910204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2018
• Device Model Number: C144F7
• Device Lot Number: 60284188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2016
• Date Manufacturer Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2016
• 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