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

Model Number	7211
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	05/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulties and shaft break occurred.The 80% in-stent restenosed (isr) target lesion was located in the severely calcified proximal left anterior descending artery (lad).A 4.00mm x 10mm wolverine coronary cutting balloon was introduced but the lesion would not yield.Rota and laser coronary angioplasty were also performed but the isr still would not fully expand.A 4.50mm x 15mm nc emerge balloon catheter was used next but the lesion still would not yield.Another 4.50mm x 8mm nc emerge balloon catheter was advanced and inflated at 22 atmospheres and afterward, the balloon could not be removed.The physician tried going neutral and negative several times.During an attempt to advance the balloon and pull it back, the shaft broke 124 cm from proximal and the distal portion of the device remained stuck in the lesion.On angiography, the balloon appeared to still be partially inflated.The physician attempted to dislodge the detached balloon by putting a wire and balloon next to it.The patient remained stable with part of the anterior wall dead and with slowing flow.The patient was sent to surgery where the balloon was removed.The patient then underwent coronary bypass from the left internal mammary artery to the lad and from a saphenous vein graft to the diagonal artery.The procedure was completed and no further patient complications were reported.
Event or Problem Description
It was reported that removal difficulties and shaft break occurred.The 80% in-stent restenosed (isr) target lesion was located in the severely calcified proximal left anterior descending artery (lad).A 4.00mm x 10mm wolverine coronary cutting balloon was introduced but the lesion would not yield.Rota and laser coronary angioplasty were also performed but the isr still would not fully expand.A 4.50mm x 15mm nc emerge balloon catheter was used next but the lesion still would not yield.Another 4.50mm x 8mm nc emerge balloon catheter was advanced and inflated at 22 atmospheres and afterward, the balloon could not be removed.The physician tried going neutral and negative several times.During an attempt to advance the balloon and pull it back, the shaft broke 124 cm from proximal and the distal portion of the device remained stuck in the lesion.On angiography, the balloon appeared to still be partially inflated.The physician attempted to dislodge the detached balloon by putting a wire and balloon next to it.The patient remained stable with part of the anterior wall dead and with slowing flow.The patient was sent to surgery where the balloon was removed.The patient then underwent coronary bypass from the left internal mammary artery to the lad and from a saphenous vein graft to the diagonal artery.The procedure was completed and no further patient complications were reported.
Additional Manufacturer Narrative
The returned product consisted of an incomplete nc emerge balloon catheter.The device was microscopically and visually examined.At 17.7cm from the strain relief the hypotube of the device was kinked/bent.There was contrast in the inflation lumen.The inflation lumen was stretched down and separated from the distal portion of the device.The total length of the returned device was 121.6cm from the strain relief.The device was missing the distal end of the inflation lumen, guidewire lumen, exit notch, balloon, and tip present upon device return.

• Brand Name: NC EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11845275
• Report Number: 2134265-2021-06377
• Device Sequence Number: 11619254
• Product Code: LOX
• UDI-Device Identifier: 08714729846314
• UDI-Public: 08714729846314
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2023
• Device Model Number: 7211
• Device Catalogue Number: 7211
• Device Lot Number: 0026911124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Weight: 132