MAUDE Adverse Event Report: CREGANNA MEDICAL ALSO D/B/A CREGANNA-TACTX MEDICAL EMPIRA NC RX PTCA POST-DILATATION CATHETER; PTCA CATHETER

Model Number 75R15300N

Device Problems Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 03/23/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation is still in progress.A follow-up mdr report will be submitted with the investigation findings.Device to be returned; not yet received.

Event Description

'this is a female patient, (b)(6) during the interventional surgery used our empiranc to expand the anterior descending lesion (stenosis rate of 80%), it's found the balloon was difficulty to deflate and then excess force to removed the balloon.The balloon was intact, no damage to blood vessels.The use of bsn stents, stent size length is unknown.'.

Manufacturer Narrative

This mdr is being made void.This incident was previously reported as a result of the complaint description initially received on (b)(6) 2017 which stated that the complaint device had failed to deflate.Even though there was no patient injury reported in this incident, this incident was reported based on this malfunction 'balloon - deflation difficulty' having previously caused a reportable mdr event, therefore setting a malfunction precedence as per mdr mfr report # 3004036480-2016-00003 where difficulty experienced in deflating the device resulted in an adverse event that required intervention.Further information received on (b)(6) 2017 and later on (b)(6) 2017 confirmed that the issue reported was that the balloon did not inflate at all and that the initial complaint description reported of deflation difficulty was incorrect.Device to be returned-not yet received.

Event Description

Initial complaint description received on (b)(6) 2017: 'this is a female patient, (b)(6)-years-old, during the interventional surgery used our empira nc to expand the anterior descending lesion (stenosis rate of (b)(6)), it's found the balloon was difficulty to deflate.Then excess force to removed the balloon.The balloon was intact, no damage to blood vessels.The use of bsn stents, stent size length is unknown.' additional information received on (b)(6) 2017: did the balloon inflate normally? - didn't inflate.What was the maximum inflation pressure? - didn't inflate.Did the balloon maintain pressure during inflation? - didn't inflate.How long did it take to deflate the balloon? - didn't inflate.Did not deflate at all? - didn't inflate.How was the balloon eventually deflated? - didn't inflate.Additional information received on (b)(6) 2017: the sales rep feedback that the balloon didn't inflate, the description as first reported was wrong.

• Brand Name: EMPIRA NC RX PTCA POST-DILATATION CATHETER
• Type of Device: PTCA CATHETER
• Manufacturer (Section D): CREGANNA MEDICAL ALSO D/B/A CREGANNA-TACTX MEDICAL; 1353 dell ave; campbell; ca 95008 95008
• Manufacturer (Section G): CREGANNA MEDICAL ALSO D/B/A CREGANNA-TACTX MEDICAL; 1353 dell ave; campbell; CA 95008
• Manufacturer Contact: mako sugimura ; 1353 dell ave; campbell, CA 95008 ; 4083647100
• MDR Report Key: 6441993
• MDR Text Key: 71100874
• Report Number: 3004036480-2017-00002
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K110133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2017

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 Expiration Date: 06/30/2017
• Device Model Number: 75R15300N
• Device Lot Number: CE1001725
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/24/2017
• Initial Date FDA Received: 03/29/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR