MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 7314

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2020

Event Type  malfunction  

Event Description

It was reported that balloon overhang occurred.Vascular access was obtained via femoral artery.The 90% stenosed, 3.5 x 20, eccentric, de novo target lesion was located in the mildly tortuous and mildly calcified left circumflex artery.Following pre-dilatation of the mid vessel with a 2.5x20 emerge balloon catheter, a non-bsc stent was implanted.Intravascular ultrasound was performed, which showed that the placed stent was under expanded.Subsequently, a 4.00mm x 20mm nc emerge balloon catheter was advanced for post-dilatation where marginal overhang was noted.A 3.5x28 synergy drug-eluting stent was advanced, and placed in the proximal vessel.Post-dilatation was performed with a 3.50mm x 20mm emerge balloon catheter where an even larger overhang was observed.Both balloons were inflated three times at 6, 12, and 20 atmospheres respectively.Overhang was noted when each of the balloons was inflated to nominal until rated burst pressure.The procedure was completed with no patient complications nor injuries reported, and the patient status was stable.

Event Description

It was reported that balloon overhang occurred.Vascular access was obtained via femoral artery.The 90% stenosed, 3.5 x 20, eccentric, de novo target lesion was located in the mildly tortuous and mildly calcified left circumflex artery.Following pre-dilatation of the mid vessel with a 2.5x20 emerge balloon catheter, a non-bsc stent was implanted.Intravascular ultrasound was performed which showed that the placed stent was under expanded.Subsequently, a 4.00mm x 20mm nc emerge balloon catheter was advanced for post-dilatation where marginal overhang was noted.A 3.5x28 synergy drug-eluting stent was advanced and placed in the proximal vessel.Post-dilatation was performed with a 3.50mm x 20mm emerge balloon catheter where an even larger overhang was observed.Both balloons were inflated three times at 6, 12, and 20 atmospheres respectively.Overhang was noted when each of the balloons was inflated to nominal until rated burst pressure.The procedure was completed with no patient complications nor injuries reported and the patient status was stable.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was contrast in the inflation lumen and balloon.The balloon was loosely folded.The device was soaked in a water bath for two days to loosen the contrast in the device.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There were no issues detected.The marker bands were 20mm apart and there were no indications of deformations on the balloon.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not find any indications of the reported defects on the balloon.

• Brand Name: NC EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10601651
• MDR Text Key: 209030339
• Report Number: 2134265-2020-12706
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

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: 03/10/2022
• Device Model Number: 7314
• Device Catalogue Number: 7314
• Device Lot Number: 0025333017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Manufacturer Received: 09/07/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER USED: 6F FR 4 LAUNCHER.; GUIDE CATHETER USED: 6F FR 4 LAUNCHER.; GUIDEWIRE USED: 0.14 WHISPER J TIP.; GUIDEWIRE USED: 0.14 WHISPER J TIP.; STENT USED: SYNERGY 3.5 X 28.; STENT USED: SYNERGY 3.5 X 28.; STENT USED: XIENCE 2.75X38.; STENT USED: XIENCE 2.75X38.; GUIDE CATHETER USED: 6F FR 4 LAUNCHER; GUIDEWIRE USED: 0.14 WHISPER J TIP; STENT USED: SYNERGY 3.5 X 28; STENT USED: XIENCE 2.75X38