MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS PREMIER; STENT, CORONARY, DRUG-ELUTING

Model Number 9553

Device Problem Entrapment of Device (1212)

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

Event Date 11/03/2023

Event Type  Injury  

Event Description

It was reported that device entrapment occurred.The 75% stenosed target lesion was located in the tortuous and partially calcified diffuse lesion of left anterior descending artery (lad) with the significant bend of exceeding 60 degrees.A 32 x 3.50mm promus premier drug eluting stent was advanced for treatment.During procedure, the catheter could not cross a non-boston scientific guidewire, the catheter got stuck with the guidewire and could not be separated when physician withdrawn the device to wipe the guidewire.After a few attempts, another non-boston scientific guidewire was passed and pulled out the stuck guidewire and catheter together.The procedure was completed successfully with another guiding catheter, guidewire, and promus premier stent.There were no patient complications reported and the patient was safe.

Manufacturer Narrative

E1: initial reporter phone: (b)(6).

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18369412
• MDR Text Key: 331047930
• Report Number: 2124215-2023-71673
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/20/2023

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 Model Number: 9553
• Device Catalogue Number: 9553
• Device Lot Number: 0031387747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2023
• 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: SION GUIDEWIRE - ASAHI
• Patient Age: 48 YR
• Patient Sex: Male