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

Model Number H7493919308200

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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 the package was not labeled correctly.During unpacking of a 2.00mm x 8mm emerge¿ balloon catheter, it was noted that the size, lot # and upn on the label of the outer box did not match the product inside the package.The item inside was a 2.50 x 8 mm emerge¿ balloon catheter with lot number; 19989107 and (b)(4).The procedure was completed with this device.There were no patient complications and the patient was "ok" following the procedure.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an emerge shelf box and pouch.The box and pouch were opened.The box was from batch number 20016815 and the pouch was from 19989107.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported that the package was not labeled correctly.During unpacking of a 2.00mm x 8mm emerge¿ balloon catheter, it was noted that the size, lot # and upn on the label of the outer box did not match the product inside the package.The item inside was a 2.50 x 8 mm emerge¿ balloon catheter with lot number; 19989107 and upn; (b)(4).The procedure was completed with this device.There were no patient complications and the patient was "ok" following the procedure.

• Brand Name: 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: 6411124
• MDR Text Key: 70185235
• Report Number: 2134265-2017-01921
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: H7493919308200
• Device Catalogue Number: 39193-0820
• Device Lot Number: 20016815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2016
• 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