MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE APEX¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H7493895915250

Device Problems Break (1069); Device Damaged by Another Device (2915)

Patient Problem Intimal Dissection (1333)

Event Date 04/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr id: 2134265-2016-04139.It was reported that vessel dissection and shaft break occurred.The target lesion was located in the right coronary artery (rca).A 2.75x38mm promus element ¿ long drug-eluting stent was advanced but failed to cross the distal lesion so the physician decided to implant the stent in the proximal lesion.Another 2.75x38mm promus element ¿ long drug-eluting stent was then advanced but also failed to cross the distal lesion.The device was removed and a 2.50mm x 15mm apex¿ balloon catheter was advanced for dilatation.However, a vessel dissection occurred.Upon removal of the device, the proximal part of the shaft of the balloon fractured in the proximal ostial of the previously implanted stent in the proximal lesion.Subsequently, 5 non-bsc balloon catheters were then used to treat the dissection.Another balloon catheter was then used to remove the fractured shaft of the balloon catheter.The previously implanted 2.75x38mm promus element ¿ long drug-eluting stent was deformed by the other devices during removal of the fractured balloon.The stent deformation was treated by implanting a non-bsc stent and the procedure was completed.No further patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an apex balloon catheter.The balloon was loosely folded.Tactile inspection revealed numerous kinks in the hypotube.Analysis could not be done as the balloon and the distal tip were not returned for analysis.Microscopic inspection revealed a separation of the outer and balloon at the proximal bond.Analysis could not be done on the inner shaft, as the inner shaft detached at the distal end of the port weld/exit notch and was not returned for analysis.Microscopic and tactile inspection of the outer shaft found no irregularities or defects.Functional testing could not be conducted due to the condition of the returned device.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The broken shaft was confirmed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Event Description

Same case as mdr id: 2134265-2016-04139.It was reported that vessel dissection and shaft break occurred.The target lesion was located in the right coronary artery (rca).A 2.75x38mm promus element ¿ long drug-eluting stent was advanced but failed to cross the distal lesion so the physician decided to implant the stent in the proximal lesion.Another 2.75x38mm promus element ¿ long drug-eluting stent was then advanced but also failed to cross the distal lesion.The device was removed and a 2.50mm x 15mm apex¿ balloon catheter was advanced for dilatation.However, a vessel dissection occurred.Upon removal of the device, the proximal part of the shaft of the balloon fractured in the proximal ostial of the previously implanted stent in the proximal lesion.Subsequently, 5 non-bsc balloon catheters were then used to treat the dissection.Another balloon catheter was then used to remove the fractured shaft of the balloon catheter.The previously implanted 2.75x38mm promus element ¿ long drug-eluting stent was deformed by the other devices during removal of the fractured balloon.The stent deformation was treated by implanting a non-bsc stent and the procedure was completed.No further patient complications were reported and the patient's status was stable.

• Brand Name: APEX¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5662598
• MDR Text Key: 45401410
• Report Number: 2134265-2016-04140
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: P860019
• 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: 04/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: H7493895915250
• Device Catalogue Number: 38959-1525
• Device Lot Number: 18442243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2015
• 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
• Patient Age: 62 YR