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

Model Number 10666

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/11/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone number - (b)(6).

Event Description

It was reported that device sterility was compromised.During unpacking of a 28 x 2.50mm promus premier select drug eluting stent, the physician found a hair in the packaging.The hair was attached at the inside of the packaging, at the inner foil of the transparent packaging.The device had not been completely removed from the packaging when the hair was found.There were no patient complications reported.

Manufacturer Narrative

E1: initial reporter phone number - (b)(6).Device evaluated by manufacturer: a sealed tyvek pouch containing a carrier tube (i.E., coiled hoop) with the promus premier select device inside was returned for product analysis.A black fiber was observed sealed inside tyvek pouch and visible at the top right corner above the label.The foreign material was not in direct contact with the carrier tubing which protects the promus premier select device.Laboratory testing of the observed fiber determined that the foreign material was consistent with a hair.

Event Description

It was reported that device sterility was compromised.During unpacking of a 28 x 2.50mm promus premier select drug eluting stent, the physician found a hair in the packaging.The hair was attached at the inside of the packaging, at the inner foil of the transparent packaging.The device had not been completely removed from the packaging when the hair was found.There were no patient complications reported.

• Brand Name: PROMUS PREMIER SELECT
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13977925
• MDR Text Key: 288391340
• Report Number: 2134265-2022-03283
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2023
• Device Model Number: 10666
• Device Catalogue Number: 10666
• Device Lot Number: 0028574203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2021
• 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