MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE NC EMERGE®; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H7493927612320

Device Problems Detachment Of Device Component (1104); Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr.: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental med watch will be filed.(b)(4).

Event Description

It was reported that balloon deflation failed, balloon and tip detachment, and catheter removal difficulties occurred.In 2006, a non-bsc stent was implanted.Six months later during a retreatment the stent was noted to be fractured.In (b)(6) 2016, patient presented with 90% in-stent restenosis of the previously deployed fractured, non-bsc stent located in the mildly tortuous and severely calcified first rpl.A 3.25mm x 12mm nc emerge® balloon catheter was advanced for dilation.After the third inflation, it was noted that the balloon would not deflate and it was suspected that the balloon got caught on the fractured stent.The patient's blood pressure was maintained using an intra-aortic balloon pump (iabp) and retrieval of the balloon was performed.A wire with high hardness at the tip was inserted at the peripheral gap of the balloon.A 3.0x15 emerge® balloon was then inserted and inflated; which enabled the 3.25mm x 12mm nc emerge® balloon catheter to detach from the fractured stent and be removed.However, the physician suspected that the distal part of the balloon and the tip were separated and left in the stent.Blood flow was secured.The procedure was completed.No further patient complications were reported and the patient was under observation.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of a nc emerge balloon catheter.There was contrast in the inflation lumen.There was blood in the wire lumen.The outer shaft, inner shaft, balloon and tip were microscopically examined.There were numerous hypotube kinks.The balloon was torn circumferentially with the distal portion of the balloon, shaft, distal markerband, and tip missing.There was no evidence of any material or manufacturing deficiencies contributing to the damage and the reported difficulty.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that balloon deflation failed, balloon and tip detachment, and catheter removal difficulties occurred.In 2006, a non-bsc stent was implanted.Six months later during a retreatment the stent was noted to be fractured.In (b)(6) 2016, patient presented with 90% in-stent restenosis of the previously deployed fractured, non-bsc stent located in the mildly tortuous and severely calcified first rpl.A 3.25mm x 12mm nc emerge® balloon catheter was advanced for dilation.After the third inflation, it was noted that the balloon would not deflate and it was suspected that the balloon got caught on the fractured stent.The patient's blood pressure was maintained using an intra-aortic balloon pump (iabp) and retrieval of the balloon was performed.A wire with high hardness at the tip was inserted at the peripheral gap of the balloon.A 3.0x15 emerge® balloon was then inserted and inflated; which enabled the 3.25mm x 12mm nc emerge® balloon catheter to detach from the fractured stent and be removed.However, the physician suspected that the distal part of the balloon and the tip were separated and left in the stent.Blood flow was secured.The procedure was completed.No further patient complications were reported and the patient was under observation.

• Brand Name: NC EMERGE®
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6194504
• MDR Text Key: 62976905
• Report Number: 2134265-2016-12058
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2016

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: 01/31/2018
• Device Model Number: H7493927612320
• Device Catalogue Number: 39276-1232
• Device Lot Number: 18872978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2016
• 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
• Treatment: CYPHHER STENT
• Patient Outcome(s): Required Intervention