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

Model Number 7162

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that blood was on the device packaging.An emerge balloon was opened from the shipping packaging.Blood was observed on the outside of the device box.The packaging was not opened.The device was not used in a procedure.

Event Description

It was reported that blood was on the device packaging.An emerge balloon was opened from the shipping packaging.Blood was observed on the outside of the device box.The packaging was not opened.The device was not used in a procedure.

Manufacturer Narrative

(b)(6).Device evaluation by mfr: the returned product consisted of an emerge catheter in the shelf box.The shelf box was received unopened.There was a blood contrast mix on "t" of boston scientific shelf box.

• Brand Name: EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9415686
• MDR Text Key: 175676321
• Report Number: 2134265-2019-14939
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• PMA/PMN Number: K130391
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

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 Expiration Date: 07/28/2020
• Device Model Number: 7162
• Device Catalogue Number: 7162
• Device Lot Number: 0021459028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2019
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 12/30/2019
• Supplement Dates FDA Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1