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

Model Number 7313

Device Problems Deflation Problem (1149); Material Rupture (1546); Failure to Deflate (4060)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2022

Event Type  Injury  

Event Description

It was reported that in-stent restenosis occurred.The patient presented with restenosis and underwent percutaneous coronary intervention.The target lesion was located in the severely tortuous mid right coronary artery.A non-boston scientific (bsc) scoring balloon was used followed by using a non-bsc guide extension catheter to place a non-bsc stent on a restenosed synergy stent implanted about 3 to 4 years ago.A 3.50mm x 15mm nc emerge balloon catheter was advanced for post-dilatation.The balloon was inflated two times at 22 atmospheres and 28 atmospheres for 30 seconds with 1:1 saline ratio.However, during the second inflation, the balloon ruptured at 25 atmospheres and the balloon could not deflate.The device was recovered by utilizing a non-bsc guide extension catheter and pulling it out.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an nc emerge balloon catheter and a non-bsc guide catheter.The device was microscopically and visually examined.The guide catheter was returned on the nc emerge balloon catheter and was able to be removed without issue or resistance.At 64.5cm from the strain relief, there was a bend in the hypotube.There was blood and contrast present to the inflation lumen and the balloon.There was blood in the guidewire lumen, and the balloon was loosely folded.At 5mm proximal to the proximal waist transition, there was a burst in the shaft.The guidewire used in the procedure was not returned so a test guidewire was used to test the device.The guidewire was inserted through the tip of the device and exited the rapid port exchange with no issue.Product analysis confirmed the reported burst, as there was a material burst of the inflation lumen.Analysis could not confirm the failure to deflate as the damage to the device prevents further functional testing.

Event Description

It was reported that in-stent restenosis occurred.The patient presented with restenosis and underwent percutaneous coronary intervention.The target lesion was located in the severely tortuous mid right coronary artery.A non-boston scientific (bsc) scoring balloon was used followed by using a non-bsc guide extension catheter to place a non-bsc stent on a restenosed synergy stent implanted about 3 to 4 years ago.A 3.50mm x 15mm nc emerge balloon catheter was advanced for post-dilatation.The balloon was inflated two times at 22 atmospheres and 28 atmospheres for 30 seconds with 1:1 saline ratio.However, during the second inflation, the balloon ruptured at 25 atmospheres and the balloon could not deflate.The device was recovered by utilizing a non-bsc guide extension catheter and pulling it out.No patient complications were reported.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15696907
• MDR Text Key: 302678771
• Report Number: 2124215-2022-42158
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

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: 05/26/2024
• Device Model Number: 7313
• Device Catalogue Number: 7313
• Device Lot Number: 0029483490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 10/29/2022
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2022
• 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